OTC - PANEL SUBMISSIONS - INDICES ONLY

17 Misc Internal 75N-0176 Request for Data and Information 77N-0094 Quinine for Treatment of Nocturnal Leg Muscle Cramps 79N-0176 Stomach Acidifiers 79N-0177 Sweet Spirits of Nitre 79N-0368 Cholecystokinetic Drugs 79N-0378 Anthelmintic Drugs 79N-0379 Exocrine Pancreatic Insufficiency Drugs 80N-0395 Hypophospatemia and Hyperphosphatemia Drug Products 80N-0419 Aphrodisiac Drug Products 81N-0022 Weight Control 81N-0027 Smoking Deterrent 81N-0040 Insect Repellent 81N-0050 Acute Toxic Ingestion 81N-0060 Orally Administered Treatment for Fever Blisters 81N-0064 Deodorant Drug Products for Internal Use 81N-0106 Digestive Aid 82N-0165 Menstrual Drug Products 82N-0166 Overindulgence in Alcohol & Food 82N-0168 Benign Prostatic Hypertrophy Stimulants 75N-0244 Tropical Antibiotics (Antimicrobial II) 76N-0482

18 19

11

Contraceptives and Other Vaginal Drug Products

80N-0280 Contraceptives 82N-0291 Vaginal 12 13 14 Memorrhoidal (Anorectal) 80N-0050 Oral Cavity 81N-0033 Antiperspirant 75N-0003 Zirconium 78N-0064 Antiperspirant Vitamin and Mineral 78N-0024 Misc External 75N-0176 Request for Data and Information 75N-0183 Mercury-containing Drug Products for Topical Antimicrobial OTC Human Use 75N-0183 Alcohol Drug Products for Topical Antimicrobial OTC Human Use 75N-0183 Diaper Rash 78N-0021 Astringent Drug Products 78N-0021 Diaper Rash 78N-0021 Externally Administered Fever Blister Drug Products 78N-0021 Insect Bite Neutralizer 78N-0021 Poison Ivy, Oak, and Sumac Prevention DRUG pRODUCTS 78N-0065 Skin Bleaching 78N-0301 Astringent Drug Products 78N-0301 Diaper Rash 78N-0301 Externally Administered Fever Blister Drug Products 78N-0301 Insect Bite Neutralizer 78N-0301 Male Genital Desensitizing 78N-0301 Poison Ivy, Oak, and Sumac Prevention Drug Products 80N-0146 Nailbiting and Thumbsucking Deterrent 80N-0227 Camphorated Oil 80N-0238 Wart Remover 80N-0348 Ingrown Toenail 80N-0357 Hair Grower and Sebum Hair Loss 80N-0476 Diaper Rash 81N-0122 Corn and Callus Remover 81N-0144 Topically Applied Hormone-containing Drug Products 82N-0054 Boil Ointment 82N-0214 Dandruff, Seborrheic Dermatitis and Psoriasis COMMENT FILES FOR PANEL SUBMISSIONS Antacid 75N-0357

15 16

01

02 03 04

Antimicrobial I 75N-0183 Internal Analgesic 77N-0094 Cough-Cold 76N-0052 76N-052B Bronchodilators 76N-052C Anticholinergics & Expectorants 76N-052G General Comments & Combinations 76N-052H Antihistamines 76N-052N Nasel Decongestants 76N-052T Antiussives Sleep-Aids 75N-0244 Topical Analgesic 77N-0334 Topical Otics 78N-0021 Skin Protectants 78N-0038 Sunscreen 78N-0301 External Analgesic Antimicrobial II 80N-0476 Topical Antifungal 81N-0114 Topical Acne Dentifrices and Dental Care Agents 78N-0196 Oral Mucosal Injury 80N-0042 Anticaries 80N-0228 Oral Discomfort Laxatives 78N-0036 78N-036A Antiemetic 78N-036D Antidiarrheal 78N-036E Emetic 78N-036L Laxative Ophthalmic 80N-0145 ACTION COMPLETED ON THE COMMENT FILES TITLE CFR PART NO. 331 & 332

05 06

07

08

09

10

01

Antacid & Antiflatulent 75N-0357

05 14 15 16 17

Sleep-Aids 75n-0244 Daytime Sleep-Aids Antiperspirnat 75N-0003 Zirconium Vitamin and Mineral 78N-0024 Misc External 80N-0227 Camphorated Oil Misc Internal 79N-0177 Sweet Spirits of Nitre 79N-0368 Cholecystokinetic Drugs

310.519 310.510 Withdrawn 310.526 310.525 357

O-T-C ANTACID DATA SUBMISSIONS
VOLUME # 01 02 03 04/05 COMPANY Plough Inc. Smith, Miller, & Parch Inc. American Cyannaid Co. Ayerst Laboratories Inc. PRODUCTS Dl-Gel liquid tablets Alzinex tablets magma Aciban Antacid tablets Riopan susp. Chew tablets

06 07/08 09 10 11 12 13 & 52

Whitehall Labs A.H. Robins Co. A.H. Robins Co. Lewis Howe Co. Arch Labs Lewis Howe Co. Wyeth Lab.

Bisodol tablets powder Bisodol plus with Belladonne plus tablets Silain tablets Silain-gel tablets liquid Robalate liquid tablets Tums liquid Dicarbosil No. 2 Liquid Milk of Magnesia A-M-T susp. Aludrox susp. Tablets Amphojel susp w/ mineral oil tablets, 300 mg. susp. 0.6 gm. tablets Basaljel Phosphaljel Titralac tablets liquid tablets for Military Aluminum Hydroxide Magnesium Trisililicate Calcium Carbonate Antacids Phillips 203 Creamalin gel. tablets Pepsamar Tablets gel. Creamalin liquid Creamalin ESP liquid tablets Tricreamalata liquid tablets

14 15 16 17 18 19 20 21 22 23

Riker Sterling Drug Sterling Drug Sterling Drug Sterling Drug Phillips, Chas. H. Winthrop Products Inc. Winthrop Lab. Winthrop Lab. Winthrop Lab. -2-

VOLUME # 24 25 26 27 28 29

COMPANY Winthrop Lab. Breon Lab Inc. Phillips, Ches. N. Co. Sterling Drug Inc. Sterling Drug Sterling Drug

PRODUCTS Wingel tablets liquids Al-Caroid tablets powder Phillips’ Milk of Magnesia Phillips’ Milk of Magnesia tab. Sal Andrews Fizrin Haley’s M-O Regular & flavored Mil-Par

30/31

Lewis Howe Co.

31 32

Arch Labs. Allen Pharmacy Boericke & Ranyon Boericke & Tafel

Tums Tums Cherry Tums Orange Tums Lemon Tums Wintergreen Dicarbosil Flik Comb. tablet #9 Comb. tablet #33 Comb. tablet #249 Alpha #46 tablet Anti-acid tablets Carbo-Pancreatin Pepsin tablets Comb. tablets #117 Digestive compound tablets Digestive mixture Flik tablets Antacid tablets Antiacid tablets Push powder Formula 1447

Bullard Co. Case Labs. Inc., G.M. Faraday Labs. Inc. G.M. Case Labs Gibbs Medicine Co. T.R. Henry Lab. Inc.

-3VOLUME # 32 COMPANY Savoy Drug & Chem’l Co. (for Vita Tone Co.) Schosburg, House of Scott Labs. Inc. 32 & 105 33 34 35/37 38 Mallinckrodt Chem’l Works Vitamininerais Inc. Marion Lab. Vick Chemical Co. Warren-Teed PRODUCTS Anacid tablets Special formula Special formula Schomburg powder Citrate of Magnesia Krem tablets VM 21 Gavisoon foamtate Vanamail Antacid tablet liquid Ratio tablets

39 40 41 42 43

Humphreys Pharmacal Inc. Garfield & Co. Beecham Inc. C.S. Dent & Co. Barnhoft Labs. Formulations Inc. Phillips-Roxane

Papsomax powder Soidlitz powders Eno Bell-ans Giycinate tablets Amaze Aids Aluminum Hydroxide Antacid 34 Hykasil Cream Magnesia and Alumina oral susp. Milk of Magnesia Digestrogen tabs. Antacid tabs. #2 Tabs Bowcid Liquid Milk of Magnesia Magnasil w/ Calcium Carbonate Milk og Magnesia Sode Mint 5 gr. white Sodium Bicarbonate 5 gr. White Sodium Bicarbonate 5 gr. Pink Maalox Camalox susp. tablet A-N-T susp. A-N-T susp. Aludrox susp. tablets Amphojel susp w/mineral oil tablets Amphojel susp tablets Basaljel Phosphaljel

43 & 45 45

Bowman Pharmaceuticals Inc. Bowman Pharmaceuticals Inc.

50 51 52 52 & 13

Rorer Inc. Rorer Inc. Wyeth Lab. Wyeth Lab.

-4VOLUME # 53/58 59 60 61 62 62 63 64/70 71/73 74/76 77/79 80 81 82 83 84 85 COMPANY Merreil-National Labs. Merreil-National Labs. Miles Lab. Inc. Upjohn Co. Medical Chemicals Co. E.R. Squibb FDA Library Miles Lab. Inc. Warner-Lambert Warner-Lambert Warner-Lambert Warner-Lambert Warner-Lambert Warner-Lambert Warner-Lambert Warner-Lambert Warner-Chilcott PRODUCTS Dalcid Kolantyl Kolantyl tabs wafers Alka Seltzer Alkets Medicil Madulox Milk of Magnesia tablet liquid Mint-o-Mag Antacid literature search Alka-Seltzer Rolaids Rolaids liquid Broomo Seltzer Macotin Gelusil Lac. Gelusil N liquid Gelusil N tablets Gelusil tablets Gelusil Flavor Pak

86 87 88 89 90 91 92 93 94 95

Warner-Lambert Church & Delight lCl American Inc. Plough Inc. Kremer Urban Co. Sterling Drug Fugi Chem. Ind. Chattem Drug & Chem. Co. Chattern Drug & Chem. Co. Wyeth

Gelusil liquid Sodium Bicarbonate Mylanta tablets liquid Mylanta II tablets liquid Kudrox tablets liquid Phillips Milk of Magnesia Neusilin A B Dihydroxyaiuminum Sodium Carbonate Algyn & Dihydroxyaiuminum Aminoacetate Aludrox Amphojel A-M-T Basaljel Phosphajel UDGA tablets Eugel tablets susp. Riopan Gel. Alka - 2 VM # 21 Aludrox etal Escot capsules Silicates Amitone tablets Riopan Mucogel O.C. Muco-25 Krem Escot Capsules Malcotabs Malcogel Anachloric A tablets Tartrates Citrocarbonate

95 95 95 96/98 99 100 101 102 103 103 104 105 106 107 108 109 110

UDGA Inc. Reid Provident Labs. Miles Miles Vitaminerals Inc. Wyeth Lab. Tutag Co. S.J. Dr. Lamar Mithchum-Thayer Inc. Ayerst Forest Labs Inc. Mallinckrodt Tutag Co. UpJohn Co. UpJohn Co. Beecham UpJohn Co.

020001

Amended -ANTIMICROBIAL DATA SUBMISSIONS

9/72

VOLUME # 1-8 9-13 14 15 16 17-18 19-20 21 22 23-28 29 30 31 32 33-40 41-43 44-46 47 48 49 50 51

COLOR Brown (or clear) Green Green Green Green Green Green Green Green Green Green Black Grey Blue Black Brown Black Red Red (or Blue) Grey Grey Black

COMPANY Givuidan Corp. Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Chesebrough-Ponds Inc. Monsanto R. Schattner Co. Ciba-Geigy Norwich Pharmacal Armour Dial Inc. Vestal Labs Fine Organics Inc. Campana Corp. Rilox Co. Colgate Palmolive

PRODUCT G-l (hexachlorophene) Zephiran Aqueous and Zobenol Aqueous Soapure and Sarene Mediquick Roccal Benzalkonium Chloride Hexachlorophene Zephiran Tincture and Zobenol Tincture Campho-Phenique PhisoHex, Fisohex and Phiso Scrub Zephiran Towellettes Vaseline First Aid Carbolate Petrolium Jelly Trichlocarban in bar soap Phenolic Compounds Irgasan DP-300 Unguentine Hexachlorophene and Trichlocarbon Septisal Temasept (Tribromsalan) Cuticura Medicated Soap Geneva Ointment Wash’n Dri Washkins for Babies

52 53 54 55 56 57 58 59 60 61 62 63 64 65-66 67 68 69-70 71

Black Black Black Black Black Black Black Blue Clear Brown Brown Clear Brown Brown Brown Tan Blue Red

Colgate Palmolive Colgate Palmolive Colgate Palmolive Colgate Palmolive Armour Dial Smith, Kline and French Smith, Kline and French Nitine Inc. Oxford Chemicals Anti-infective Literature Search, Ayerst Laboratories Defense Med. Purchase Descriptions-Detergent U.S. Borax Miscellaneous Submissions Ferro Corp. Phenix Armour Dial West Chemical

Washkins (hospital pack) Wash’n Dri (professional) Dermassage Lotion Tackel Gel Tribrosalan Pragmatar Acnomel Cream, Cake Nitex Hexachlorophene FDA Library Dermoplast Aerosol Providene Iodine MD-7, Tomac, Luron

Ottasept Phenix Fungicide Hexachlorophene Iodophers

0

Amended---9/72 ANTIMICROBIAL DATA SUBMISSIONS

VOLUME # 1-8 9-13 14 15 16 17-18 19-20 21 22 23-28 29 30 31 32 33-40 41-43 44-46 47 48 49 50 51 52 53 54 55 56 57 58

COLOR Brown (or clear) Green Green Green Geen Green Green Green Green Green Green Black Grey Blue Black Brown Black Red Red (or Blue) Grey Grey Black Black Black Black Black Black Black Black

COMPANY Givuidan Corp. Sterling Drug Inc. Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Sterling Drug Chesebrough-Ponds Inc. Monsanto R. Schatttner Co. Ciba-Geigy Norwich Pharmacal Armour Dial Inc. Vestal Labs Dis Chemical Corp Fine Organics Inc. Campana Corp. Rilox Co. Colgate Palmolive Colgate Palmolive Colgate Palmolive Colgate Palmolive Colgate Palmolive Armour Dial Smith, Kline and French Smith, Kline and French

PRODUCT G-l (hexachlorophene) Zephiran Aqueous and Zobenol Aqueous Soapure and Sarene Mediquick Roccal Benzalkonium Chloride Hexachlorophene Zephiran Tincture and Zobenol Tincture Campo-Phenique PhisoHex, Fisohex and Phiso Scrub Zephiran Towellettes Vaseline First Aid Carbolate Petrolium Jelly Trichlocarban in bar soap Phenolic Compounds Oraderm lip Lotion Chloraderm Liquid Irgasan DP-300 Unguentine Hexachlorophene and Trichlocarban Septisol Temasept (Tribromsalan) Cuticura Medicated Soap Geneva Ointment Wash’n Dri Washkins for Babies Washkins (hospital pack) Wash’n Dri (professinal) Dermassage Lotion Tackel Gel Tribromsalan Pragmatar Acnomel Cream, Cake

59 60 61 62 63 64 65-66 67 68 69-70 71 72 73 74-76 77-79 80-82 83 84 85 86 87-91 92 93 94 95 96 97 98 99 100 101

Blue Clear Brown Brown Clear Brown Brown Brown Tan Blue Red Brown Tan Brown Brown Blue Black Brown Tan Blue Black (looseleaf) Clear Black Brown Clear Clear Clear Brown Brown Brown Brown

Nitine Inc. Oxford Chemicals Disconsolidated Food Corp Anti-infective Literature Search Ayerst Laboratories Defense Med. Purchase Descriptions U.S. Borax Miscellaneous Submissions Ferro Corp. Phenix Armour Dial West Chemical Chesebrough Ponds Inc. R.T. Vanderbilt Plough Inc. Plough Inc. Merck, Sharp & Dohme Proctor and Gamble C.R. Canfield & Co. High Chemical Company Merck, Sharp & Dohme Miles Labs C.R. Canfield UpJohn Co. Plough, Inc. Marika Armour Dial Sterling Drug Purdue Frederick Purdue Frederick Purdue Frederick Purdue Frederick

Nitex Hexachlorophene FDA Library Dermoplast Aerosol Detergent, Providone, Iodine MD-7, Tomac, Luron

Ottasept Phenix Fungicide Hexachlorophene Iodophors Virac Topical Germacide Vancide Solarcaine Maxana Medicated Powder ST 37 Antiseptic Safeguard Sebacide Klorlyptus Approve Bactine Sebacide Mercresin Clean’n Treat Verdi Lotion Dial and Safeguard Supp. PhisoHex Betadine Cleanser Betadine Antiseptic Betadine Aerosol Spray Betadine Ointment

162 103 104 105 106 107 108-113 114

Brown Brown Brown Brown Brown Blue Red or Yellow Yellow (3 copies only) 1. Mrs. Bruch 2. Dr. Epstein 3. Dr. Kinoshita Blue Clear Black Black Blue Black Blue Yellow or Red Black Black

Sterling DRUG Armour Dial, Inc. CIBA-GEIGY Pfister FDA Literature Search Supplement #1 Lever Brothers Lever Brothers Lever Brothers

Tribromosalicylanilide Hexachlorophene Irgasan DP 300 Triclosan Tribromosalicylanilide Dichloro-m-Xylenol O-Phenyl-Phenol Pyrithione Zinc Tribromsalan Tribromsalan Tribromsalan

115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133

FDA Literature Search Supplement #2 Ciba Geigy Colgate Colgate Purdue Frederick Sherwin Williams Merck, Sharp & Dohme (IND # 6355) Lever Brothers Armour Dial Inc. Armour Dial Inc.

Quaternary Ammonium Compounds Irgasan DP-300 P-300 Soap Bar P-300 Soap Bar Betadine Providone-iodine Tribromosalicylanilide 5-Chloro-2 (2.4 DichloroPhenoxy) Phenol Tribromsalan Triclocarban Summary Report Triclocarban Raw Data 3 Volumes combined in one Jacket (except Dr. Kinoshita’s) Triclocarbon Benzethonium Chloride (Phemerol) Pragmator (Labeling Change) FDA Health Practices and Opinions Study Ionol (BHT) TBS 1972-73 Antibacterial animal studies Preliminary Report TCC, TFC, BSA, HCP

Brown Brown Black Clear Clear Yellow Yellow Clear or Clear

Armour Dial Inc. Armour Dial Inc. Parke Davis Smith, Kline & French FDA West Chemical Fine Organics Inc. Proctor & Gamble

134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150

Green Gray Blue Blue Green Brown Gray Gray Black Gray Red Gray Black Gray Yellow Yellow Yellow

Sterling Drug Norwich Pharmacal Sterling Drug Sterling Drug FDA Literature Search Supplement #2 (abstracts) Procter & Gamble West Chemical lCl America CIBA-GEIGY Sterling Drug FDA Chesebrough Pond, Inc. Rystan R. Schattner Company Procter & Gamble Company Jerry M. Rice, Ph.D Ncl Peter S. Herman, MBBS, MSC, CSPR; University of Sherbrooke Quebec, Canada Sterling Drug Inc. Chesebrough Ponds, Inc. Ciba-Geigy Corp. Ciba-Geigy Corp. Colgate-Palmolive Company Ferro Corp. West Chemical FDA The Purdue Frederick Co.

Zephiran Cl. Unquentine Tribromo Salicylanilide Tribromo Salicylanilide Quaternary Ammonium Compound 91 Day, Rat Feeding Study with HCl, TBS, TCC, TFC Iodophors Hibitane (chlorhexidine Gluconate) submission dated 10-13-72 to BD-120 Irgasan DP-300 Methylbenzethonium chloride Article on “Triple Dyd” (Dr. Lockhart) Addendum to VIRAC Sodium Propioxiate Chlorophyll (Prophyllin) Chloraderm (invivo data) 28 Day Rabbitt Study HCP, BSA, TCC, TFC Letter to Dr. Francis Margulli, FDA Toxicity & Carcinogenicity of PVP Letter to Mary Bruch Executive Secretary, OTC Panel Individual Brain Weights of rats TBS Study Virac Supplemental Information (New PDR Section) Irgasan CF3 Cloflucarban Additional Safety Data Iragasan CF3 Cloflucarban Additional Safety Data Letter to Panel Chairman re: TBS Additional test data on Otrasept Additional data on Iodophors Cross Index to Submission Additional Data on Betadine

151 152 153 154 155 156 157 158 159

Yellow Yellow Black Black Yellow Various Colors Red Blue Clear (and Blue)

160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176

Clear Red Brown Brown Yellow Brown Black Black Black Red Blue Yellow Brown Clear Blue Black Blue

Ferro Corp. Ottawa Chemical Div. West Chemical Products Inc. Huntington Laboratories Inc. Sterling Drug Inc. Letters from various dermatologists Monsanto Ciba-Geigy Corp. Ciba-Geigy Corp. Ciba-Geigy Corp. Lever Brothers Co. Lever Brothers Co. Winthrop Laboratories Fine Organics Fine Organics Sterling Chesebrough-Ponds, Inc.
W. Mitchel Sams, Jr., M.D. Prof. And Head Division of Dermatology University of Colorado Med. Center Denver, Colorado

Additional Data on pchloro-xylenol Additional Data on Iodophors Iodophors Additional Data on TBS re: TBS TCC Iragasan (CF 3) Additional Data Iragasan (DP 300) Additional Data Iragasan (DP 300) Additional Data TBS Additional Data Irgasan (DP 300) Comments on Proposed Definitions and Guidelines TBS Additional Data (Summary) TBS Additional Data Phisohex-Final Report Infant Monkey Study Additional Data; Vasoline Carbolated Petroleum Jelly Letter regarding TBS

177 178 179 180

Blue

West Chemical Products, Inc. FDA Onyx Chemical Company Jersey City, NJ 07302

Yellow

Colgate-Palmolive

181 182 183

Red Black Black

West Chemical Products, Inc. Colgate-Palmolive Colgate-Palmolive

Comments on Panels Proposed Definitions Misc. Reports (Proctor and Gamble NDA) Toxicity data on Quaternary Ammonium Compounds Additional data on Dermassage - Comments on Oxyquinoline Sulfate as an active ingredient Iodine Bibliography Additional animal safety data on Irgasan, HCP & TBS

184 185 186 187 188 189 190 191

Black Black

Colgate-Palmolive Colgate-Palmolive Misc. FDA Reports Fine Organics Bristal-Myers Co. Monsanto FDA FDA 90 Day Subacute Rat Study on TBS Presentation on Skin Antiseptics TCC Reproduction Study Additional data on Phenol Misc. Uncited Ref.

Topical Antimicrobial Drug Products for OTC Human Use Establishment of a Monograph and Reopening of Administrative Record Docket No. 75N-0183 Volume 02APA1 In the FEDERAL REGISTER of September 7, 1982 (47 FR 39406), the administrative record for the OTC topical antimicrobial drug products rulemaking was reopened to include a statement on OTC Drug Products for the Treatment of Diaper Rash by the Advisory Review Panel on OTC Miscellaneous External Drug Products. To avoid duplication, the Public Administrative File for that statement appears as part of the administrative file for the OTC external analgesic drug products rulemaking (Docket No. 78N-0301) that was also reopened on September 7, 1982 (47 FR 39412). The material included in the topical antifungal rulemaking is identified in OTC Volume 06BPA6 in the external analgesic administrative file.

DATA AND INFORMATION
Volume 030001 030002 030003 030004 030005 030006 030007 Submittted by Plough, Inc. Memphis, Tenn. Plough, Inc. A.H. Robins Co. Richmond, VA A.H. Robins Co. Warner Lambert Co. Morris Plains, N.Y. Trade Name St. Joseph Aspirin for Children St. Joseph Aspirin Arthralgen Tablets Pabalate Tablets Bromo Seltzer Ingredients Listed Aspirin Aspirin Sallcylamide Acetaminophen Sodium Sallcylate (PABA) Sodium Aminobenzoate Acetaminophen Phenacetin Potassium bromide Caffeine Sodium bicarbonate Citric acid Aspirin Mono-calcium phosphate Sodium bicarbonate Citric acid

030008 to 030015

Miles Laboratories Inc. Elkhart, Indiana

Alka-Seltzer

030016 to 030029 030030 to 030032 030033 to 030035 030036 030037 030038 030039

McNeil Laboratories, Inc. Camp Hill Road Fort Washington, PA 19034 McNeil McNeil McNeil Abbott Laboratories North Chicago, Ill 60064
Smith Kline & French Lab. 15000 Spring Carden St. Philadelphia, Pa 19101

Tylenol Tablets

Acetaminophen

Tylenol Elixir Tylenol Chewable Tablets Tylenol Drops Children’s Chewable Tab. Ecotrin, enteric coated Tenlap Elixir

Acetaminophen Acetaminophen Acetaminophen Aluminum Aspirin Aspirin Acetaminophen

030040 030041 030042 030043

The Dow Chemical Co. Research Center P.O. Box 10 Zionsville, Indiana 46077 The Dow Chemical Co. Plough, Inc. Memphis, Texas 38101 Warren-Teed Pharm. Inc. Columbus, Ohio 43215
Whitehall Laboratories Inc. 685 Thrid Avenue New York, N.Y. 10017

Phensal Tablets Aspergum Magan Tablets Duplexin Tablets

Aspirin Phenacetin Caffeine Aspirin Magnesium Salicylate Dihydroxy Aluminum Sodium Carbonate Magnesium Carbonate Aspirin Phenacetin Caffeine Micronized Aspirin Dried Aluminum Hydroxide gel Magnesium Hydroxide Aspirin Caffeine Salicylsalicylic Acid (Salsalate) Acetaminophen Acetaminophen Saliylamide Caffeine Pyrilamine Maleate Homatropine Methylbromide Acetaminophen Salicylamide Caffeine Calcium Carbaspirin

030044

Whitehall Labs Inc.

Arthritis Pain Formula

030045 030046 030047 030048

Whitehall Labs Whitehall Labs
VSV Pharmaceutical Corp. 1 Scarsdalle Road Tuckahoe, New York 10707

Anacin Saloxium Tablet Liquiprin Suspension Femicin Tablets

USV

030049 030050

USV Dorsey Laboratories Box 83288 Lincoln, Nebraska 68501

Comeback Tablets Calurin Tablets

030051

Dorsey

Cama Inlay Tabs

030052

Dorsey

Chexit Tablets

030053

Dorsey

Pabirin Tablets

030054

Dorsey

Triaminicin Tablets

030055

Dorsey

Tussagesic Tablets/Suspension

030056

Dorsey

Ursinus Inlay Tabs

030057 030058

Mead Johnson Research Center Evansville, Indiana 47721 Block Drug Company Inc.

Tempra Drops,Syrup, Tablet BC Powder BC Tablet

030059 030060

030061 030062

William H. Rorer Inc. Fort Washington, Pa 19034 Monsanto Industrial Chemicals Co. 800 N. Lindbergh Boulevard St. Louis, Missouri 63166 Monsanto Monsanto

Ascriptin Tablet Salicylamide

Aspirin (10 grains) Magesium hydroxide Aluminum hydroxide dried gel Phenylpropanaolamine hydrochloride Pheniramine maleate Phrilamine maleate Dextromethorphan hydrobromide Terpin hydrate Acetaminophen Aspirin Aminobenzomic acid dried aluminum hydroxide gel Phenylpropanolamine hydrochloride Pheniramine maleate Pyrilamine maleate Aspirin Acetaminophen Caffeine Ascorbic acid Phenylpropanolamine hydrochloride Pheniramine maleate Pyrilamine maleate Dextromethorphan hydrobromide Terpin hydrate Acetaminophen Calcium Carbaspirin Phenylpropanolamine hydrochloride Phyrilamine maleate Acetaminophen (Drops) (Syrup) (Tablets) Aspirin Salicylamide Caffeine Aspirin Salicylamide Caffeine Aspirin Magnesium Hydroxide Aluminum Hydroxide (No dosage form)

Aspirin Phenacetin

(No dosage form) (No dosage form)

030063

J. Maxwell Little, Ph.D. Professor & Chairman Dept. Of Pharmacology Bowman Gray School of Medicine Sterling Drug Inc. 90 Park Avenue New York, N.Y. 10016

Headache Powders

030064

Bayer Aspirin tablets Bayer Children’s Aspirin Bayer Timed-Release Measurin Tablets Cortal para Ninos Fizrin

030065

Sterling

Mejoral Cafenol Tablet Cafiaspirina Tablet

030066

Sterling

Midol

030067

Sterling

Vanquish

030068

Sterling

Cope

Phenacetin Caffeine Citric acid Potassium chloride Lactose Aspirin Aspirin Aspirin Aspirin Aspirin Aspirin Aspirin Sodium Bicarbonate Sodium Carbonate Citric Acid Aspirin Caffeine Aspirin Caffeine Aspirin Caffeine Aspirin Cinnamedrin hydrochloride Caffeine Aspirin Acetaminophen Caffeine Dried Aluminum hydroxide gel Magnesium hydroxide Aspirin Caffeine Methapyrilene fumarate Magnesium hydroxide Dried Aluminum hydroxide gel

030069 to 030072

Bristol-Myers Products New York, New York

Bufferin

Aspirin Magnesium Carbonate Dihydroxyaluminum aminoacetate Aspirin Magnesium carbonate Dithydroxyaluminum aminoacetate Aspirin Acetaminophen Caffeine Salicylamide Aspirin Salicylamide Acetaminophen Methapyrilene fumarate Aspirin Sodium bicarbonate Powdered citric acid Monocalcium phosphate Calcium carbaspirin Phenylpropanolamine hydrochoride Pheniramine maleate Pyrilamine maleate Aspirin Acetaminophen Caffeine Acetylsalicylic acid Acetaminophen Acetaminophen Acetaminophen Aspirin Caffeine Aspirin Caffeine Choline Salicylate

Arthritis Strength Bufferin

Excedrin

Excedrin P.M.

Disolve

030073

Sandoz Pharmaceuticals

Fiogesic Tablets

030074

E.R. Squibb & Sons Inc.

Aspirin Tablets Trigesic Tablets

Valadol Liquid Valadol Tablets 030075 030076 030077 Templetons Inc. Buffalo, New York Fountain Labs, Inc. The Purdue Frederick Co. Valadol Chewable Tablets Templeton’‘s T-R-C’s PANO Arthropan Liquid

030078

Federal Register Notice of April 20, 1972 and NAS/NRC Reports

Surfacaine Suppositories Bufferin Tablets

Cyclomethycaine Aspirin Aluminum Glycinate Magnesium Carbonate Acetaminophen Aspirin Caffeine Acetaminophen Acetaminophen Acetaminophen Dihydroxyaluminum Sodium Carbonate Magnesium Carbonate Aspirin Phenacetin Caffeine Acetaminophen Acetaminophen Acetaminophen Acetaminophen Acetaminophen Choline Salicylate Choline Salicylate Glycerylguaiacolate Aspirin Phenyltoloxamine Dihydrogen Citrate Aspirin

Trigesic Tablets

Nebs Tablets Apamide Tablets Metalid Tablets Duplexin Tablets

Nysacetol Tablets Tylenol Elixir Tempra Drops, Syrup Tralgon Elixir Tylenol Tablets Arthropan Liquid Actasal Pediatric Drops Defencin Tablets

030079 030080 030081 030082 030083 to 030086

The Upjohn Company

Aspirin Tablets

P-A-C Compound Tablets, Phenacetin Capsules Aspirin Caffeine Acetonyl Effervescent Salt Aspirin Salicionyl Effervescent Salt Sinutab Sodium Salicylate Sodium Bicarbonate Acetaminophen Phenacetin Phenylpropanolamine HCl Phenylpropanolamine Citrate Acetaminophen Phenacetin Phenylpropanolamine HCl Aspirin Acetaminophen Acetaminophen

Warner-Chilcott Laboratories

Sinutab ll 030087 030088 to 030090 Norwich Pharmacal Co. Aspirin Nebs Tablets Nebs Elixir

030091 (labels only)

Eneglotaria Medicine Co. of Pureto Rico L.W. Estes Co., Inc. The Rilox Co. R.L. Gaddy Pharmacist

Pediascirin Syrup Estes Nu-Ral Tablets Baltar’s Medium EZ-IT Tablets Persistin Curtis A-R Pain Relief

Acetaminophen Aspirin Caffeine Sodium Salicylate Potassium Iodide Cascara Sagrade Aspirin Phenacetin Caffeine Salicylsalicylic acid Aspirin Sodium Sallcylate Sodium Para Aminobenzoate Vitamin C (Ascorbic Acid) Vitamin B (Thiamin Hydrochloride) Vitamin B (Riboflavin)

030092 030093 (labels only)

McMurray & Pendergast for Cooper Labs. Inc. Curtis Drug Co.

Berry & Withington Co.

Sodium Salicylate Aspirin Buffered Aspirin Aspirin Glycline, Aluminum Hydroxide Magnesium Carbonate Aspirin Penacetin Caffeine Aspirin Phenacetin Caffeine Aspirin Phenacetin Caffeine Codeine Phosphate

Aspirin Compound No.2 030093 (cont.) Republic Drug Co. A.P.C. Tablets A.P.C. with Codeline

Aspirin Buffered Aspirin Aspirin Aluminum Hydroxide Glycine Magnesium Carbonate N-Acetyl-p-aminophenol Salicylamide Aspirin Caffeine Acetaminophen

Superin

Tapanol

Boericke & Tafel

Boericke & Runyon Tablets No. 200

Boericke & Tafel

B & R Tablet No. 171A

Acetanilid Caffeine Sodium Bicarbonate Calomel Iris Versicolor Nux Vomica Henatyne (represents Acetylsalicylic 1/10 gr. And Magnesium Oxide 2/10 gr.) Acetylsalicylic Acid Macrotin Bryonin Sodium Salicylate

Lewis’ Mfg. Co. 030094 030095 Prepared bt Lee M. Quon, OTC Staff Miles Laboratories

030096 030097 030098 030099 030100 030101 030102 030103

T.E. Watson Co. American Felsol Co. Division Edgar Larsen T.E. Watson Co. T.E. Watson Co. T.E. Watson Co. T.E. Watson Co. Sterling Drug Inc. Bristol-Myers Co.

Dr. Lewis’ Preparation for Rheumatism Comparative Toxicity of Phenacetin and Acetaminophen Prepared by Allen R. Cooke, M.D. The Role of Acid in the Pathogenesis of Aspirin Induced Gastronintestinal Erosions and Hemorrhage Felsol Powders Felsol Tablets Hoover Powders

Antipyrine Iodopyrine Citrated Caffeine Acetanilid Caffeine Sodium Bicarbonate Antipyrine Antipyrine Antipyrine Antipyrine

Vanquish addition Remarks concerning the safety and effectiveness of Caffeine in combination with aspirin-order analgesic with special reference to Excedrin Alka Seltzer-Safety And Effectiveness of a Buffered Sodium Acetylsalicylate Solution References for Volume 030104 Presentation to the Panel on Bufferin and Excedrin

Acetaminophen literature

030104

Miles Laboratories Inc.

030105 to 030112 030113

Miles Laboratories Inc. Bristol-Myers Products

030114 and 030115

Bristol-Myers Products

Excedrin P.M.

Aspirin Salicylamide Acetaminophen Methapyrilene Fumarate

030116 030117 030118 030119 030120 030121 to 030124 030125 to 030127 030128 030129 030130 030131

Plough, Inc. Bristol-Myers Products Plough, Inc. Smith Kling & French Laboratories T.E. Watson Co. Miles Laboratories Whitehall Laboratories

Aspergum - Additional data Duration of Action Bufferin compared to standard aspirin Aspergum - additional data #2 Ecotrin - additional data Felsol (Additional Data) Alka-Seltzer (Additional Data) Anacin Arthritis Pain Formula (Additional Data Prepared by Clinical Resources, Inc.) Acetaminophen Acetaminophen (additional data) Additional data Micronized Aspirin General Comments on Buffered Analgesics Percogesic Dilone Antipyrine

McNeil Laboratories, Inc. Whitehall Laboratories Ciba-Geigy Corp. Endo Laboratories, Inc.

Acetaminophen Phenyltoloxamine citrate Acetaminophen Phenyltoloxamine citrate Caffeine

030132 030133 030134 030135 030136 to 030138 030139 030140 030141

Miles Labs., Inc. Sterling Drug Inc. Burroughs Wellcome Co. Warner-Lambert Res. Inst. Bristol-Myers Products Bristol-Myers Products Eli Lilly & Co. Glenbrook Laboratories, Division of Sterling Drug, Inc.

References for AlkaSeltzer Additional Information Additional Information Additional Information on Acetaminophen Bromo-Seltzer Sodium bicarbonate Citric Acid Bufferin Additional information Bufferin Aspirin Suppositories Information on Acetaminophen Additional Information Aspirin

030142 030143 and 030144 030145 030146 030147 030148 030149 030150 030151 030152 030153 030154 030155 030156 030157 030158 030159

Plough, Inc. American Home Products and Bristol-Myers Products T.E. Watson Co. S.B. Penick & Co. Miles Laboratories Inc. Bristol-Myers Products Sterling Drug Inc. OTC Division McNeil Laboratories Reprints and bibliography on analgesic nephropathy Bristol-Myers Endo

Additional inforamtion on St. Joseph Aspirin for Children Joint presentation to the 24th Panel meeting “arthritis in the label” Felsol Powder and Tablet Salicylamide bibliography Additional data on AlkaSeltzer Crystal size data on aspirin Dr. Fallier’s presentation on 9/25/74 General data collection Abstract of Study by Drs. Cooper and Beaver Excedrin Percogesic

additional information

Additional data Acetaminophen phenyltoloxamine

Whitehall Laboratories Warner-Lambert Company Glenbrook Laboratories Division of Sterling Drug, Inc. Primer on the Rheumatic Diseases, Prepared by a Committee of the American Rheumatism Association Section of the Arthritis Foundation, 1973 Bristol-Myers McNeil Laboratories, Inc. Miles Laboratories, Inc. Endo Laboratories, Inc.

Saloxium, Bromo-Seltzer Information, and reprints, on aspirin

additional data additional data

030160 030161 030162 030163

Neolin Acetaminophen Alka-Seltzer Percogesic

Aspirin Magnesium carbonate Calcium carbonate Pediatric dose comments, data Additional information Additional information

030164

Burroughs Wellcome Co. Block Drug Co., Inc. The Proprietary Assn. Plough, Inc. Vick Divisions Reseach/Vick Chemical Co.

030165

Bristol-Myers Products Endo Laboratories

Percogesic

additional information presented at the November 22, 1976 meeting.

030166 030167 030168 030169 030170

Glenbrook Laboratories, Division of Sterling Drug, Inc. Miles Laboratories, Inc. American Home Products Corp. Various memoranda of discussions and evaluations of Percogesic Miles Laboratories

Supplemental Data on Alka-Seltzer, dated October 30, 1974, Master List of References

030171 030172 030173 030174 030175 030176 030177 030178 030179 030180 Negative responses to request for data--38 companies Summary minutes of Panel meetings #1-#28 Bibiography, 1972 compiled by FDA Medical Library FDA-OTC Literature Search FDA-OTC Literature Search FDA-OTC Literature Search FDA-OTC Literature Search Federal Trade Commission The Propietary Association, position statement for discussion of labeling at the August 21-23, 1976 meeting

Abstract Bibiography Abstract Bibliography Abstract Bibliography Abstract Bibliography Comments on preliminary Draft #6

Aspirin, 1972 Phenacetin, 1972 Caffeine, 1972 Internal Analgesics other than aspirin, phenacetin, caffeine, 1972

030181

030182

Various Submissions, Memoranda, etc. regarding aspirin, phenacetin Various Submissions, Memoranda, etc. regarding acetaminophen, antipyrine, caffeine

CCABA SUBMISSION CHART Volume Number 040001 to 040004 040005 040006 to 040009 040010 040011 040012 to 040018 040019 040020 to 040021 Submittor Merck Chem. Division Thomas Davis Chesebrough-Ponds McNeil Laboratories Patrick H. Seay, Ph.D. Monsanto Creomulsion Co. Pennwalt Smith Kline & French Smith Kline & French Subject Noscapine Pertussin Co-Tylenol Cold Formula Tablets Methapyrilene Hcl Creomulsion Allerest Ornex Benzedrex

040021 040022 040023 to 040025 040026 040027 040028 040029 to 040046 040032 040047 to 040055 040056 to 040060 040060A 040061 to 040063 040063 040064 040065 to 040066 040067 040068 040069 to 040070 040071 to 040072 040073 to 040079 040080 040081 to 040083 040084 040085 040086

Smith Kline & French Ludens Calgon Consumer Products Jane Howell A.H. Robins Co. Robitussin Pennwalt

Ornacol Cough Drops Sucrets Glyceryl guaiacolate Sinarest Tablets

Johnson & Johnson USV Pharmaceutical Corp. Vicks Chemical Co. Vicks Chemical Co.

Sine-aid Liquiprin Nyquil Nighttime Cold Medicine Vicks Vapor Rub

Vicks Chemical Co. USV Pharmaceutical Corp. Vicks Chemical Co. Vicks Chemical Co. Vicks Chemical Co. Vicks Chemical Co. Vicks Chemical Co. Vicks Chemical Co. Vicks Chemical Co. Father John Medicine Gerald Donehue Schering Corp. Ken Brilhart Hoffman-LaRoche Hoffman-LaRoche Hoffman-LaRoche

Vicks Cough Drop Vaponefrin/Asthmanefrin Vicks Cough Syrup Vick Inhaler Vick Cough Silencer Formula 44D Cough Syrup Formula 44D Cough Syrup Sinex Nasal Spray Formula 44D Cough Discs Formula 44 Cough Mixture Cough Syrup Coricidin Chlor-Trimeton Afrin Romilar Syrup Romilar Expectorant Romilar HB Tablets

040087 040088 040089 040090 040091 040092 040093 040094 040095 040096 040097 040098 040099 040100 040102 040103 040104 040105 040106 040107 040108 040109 040110 040111 040112 040113 040114 040115 040116 040117 040118

Hoffman-LaRoche Hoffman-LaRoche Hoffman-LaRoche Hoffman-LaRoche Hoffman-LaRoche Hoffman-LaRoche Hoffman- LaRoche Hoffman-LaRoche Chesebrough-Ponds Chesebrough-Ponds Chesebrough-Ponds Knoll Pharm. Co. USV Pharmaceutical Corp. USV Pharmaceutical Corp. Abbott Laboratories Abbott Laboratories A.H. Robins Co. A.H. Robins Co. A.H. Robins Co. Ciba-Geigy Corp. LaWall & Harrison Donald Abbott The Dow Chemical Co. The Dow Chemical Co. The Dow Chemical Co. The Dow Chemical Co. The Dow Chemical Co. The Dow Chemical Co. The Dow Chemical Co. Ives Labs. Inc. Ives Labs. Inc. The Mentholatum Co.

Romilar CF Syrup Romilar CF Capsules Romilar Cough and Cold Capsules Children’s Romilar Syrup Romilar CF 8-Hr. Syrup Romilar Cough Discs Romilar Chewable Cough Tablets Romilar III Pertussin Wild Berry Cough Syrup Pertussin Medicated Vaporizer Pertussin Plus Nighttime Cold Medicine Verequad Arrestin Vaponefrin/Asthmanefrin Quelidrine Cough Syrup Calcidrine Syrup Robitussets Troches Robitussin PE Syrup Robitussin DM Syrup Otrivin Nasel Solution and Spray Troutman’s Cough Syrup 2/G Novahistine-Elixir Novahistine 2 G/DM Novahistine Expectorant Novahistine - Special Study Addendum Novahistine Fortia Cerose DM Cerose Mentholatum Ointment

040119 040120 040121 040122 040123 040124 040125 040126 040127 040128 040129 040130 040131 040132 040133 040134 040135 040136 040137 040138 040139 040140 040141 040142 to 040146 040147 040148 040149 040150 040151 040152 040153

Whitehall Labs. Inc. Whitehall Labs. Inc. Whitehall Labs. Inc. Whitehall Labs. Inc. Whitehall Labs. Inc. Whitehall Labs. Inc. Whitehall Labs. Inc. Whitehall Labs. Inc. Whitehall labs. Inc. Whitehall labs. Inc. Ives Labs. Inc. Ives Labs. Inc. Warner-Lambert Co. Warner-Lambert Co. Warner-Lambert Co. Warner-Lambert Co. Warner-Lambert Co. Warner-Lambert Co. Warner-Lambert Co. Warner-Lambert Co. Ciba-Geigy The Dow Chemical Co. Plough, Inc. Merck/Calgon Consumer Products Dorsey Laboratories Dorsey Laboratories Dorsey Laboratories Dorsey Laboratories Dorsey Laboratories Dorsey Laboratories Dorsey Laboratories

Dondrill Anticough Tablets Dristan Capsules Primatene Asthma Tablets (P) Primatene Asthma Tablets (M) Dristan Nasal Mist and Vapor Spray Clear and dry Tablets Dristan Cough Formula Liquid Dristan Decongestant Tablets Primetime and Bronitin Mist Bronitin Tablets Cerose Compond Cetro-Cirose Listerine Cough Control Lozenge Super Anahist Decongestant Nasal Spray Big 4 Cough Formula Listerine Antiseptic Lozenge Smith Brothers Cough Discs Hall’s Cough Tablets Listerine Cold Tablets Super Anahist Decongestant Tablets Privine Nasal Solution and Spray Novahistine Melet St. Joseph’s Cough Syrup for Children Sucrets Cold Decongestant Formula Dorcol Pediatric Cough Syrup Dor-C Tablets Chexit Tablets Triaminic Expectorant Triaminic Syrup Triaminicin Nasal Spray Triaminicin Tablets

040154 040155 040156 040157 040158 040159 040160 040161 040162 040163 040164 040165 040166

Dorsey Laboratories Dorsey Laboratories Dorsey Laboratories Merck Sharp & Dohme Merck Sharp & Dohme Sterling Drug, Inc. Sterling Drug, Inc. Sterling Drug, Inc. Sterling Drug, Inc. Sterling Drug, Inc. Sterling Drug, Inc. Sterling Drug, Inc. Sterling Drug, Inc.

Triaminicol Cough Syrup TussagesicR Tablets and Suspension Ursinus Inlay Tabs Capsules & Elixer Propadrine Capsules & Elixer Propadrine Deka Cough Syrup Neo-Synephrine Elixir Breacol Cough Medicine Bronkaid Mist Breacol with Prylon Cough Medicine Synephicol Cough Syrup Recindal Cough Medicine Bronkotabs Bronkotabs HAFS Bronkolixer Bronkaid Tabs NTR, NTZ, NRT Nose Drops and Nasal Spray Neo-Synephrine Nose Drops & Nasal Spray Neo-Synephrine Asafen Synephricol Bibliography Pertussin Cold-Team-24 Quadrin Elixir Terpin Hydrate Baby Cough Syrup Amodrine Coryban-D Nasal Spray Coryban-D Cough Syrup Coryban-D Cold Capsules Cheracol, Cheracol D Cheracol Bilingual Orthoxicol (Orthoxine Cough Syrup) Alka Seltzer

040167 040168 040169 040170 040171 040172 040173 040174 040175 040176 040177 040178 to 040189 040190 040191 040192 to 040193

Sterling Drug, Inc. Sterling Drug, Inc. Sterling Drug, Inc. FDA Library Chesebrough-Ponds Norwich Pharmacal Co. Norwich Pharmacal Co. Norwich Pharmacal Co. Searle Laboratories Pfizer Inc. Pfizer Inc. Pfizer Inc. The UpJohn Co. The UpJohn Co. Miles labs.

040194 to 040197 040198 040199 to 040200 040201 040202 040203 040204 040205 040206 040207 040208 040209 040210 040211 040212 040213 040214 040215 040216 040217 040218 040219 040220 040221 040222 040223 to 040224 040225 040226

A.H. robins Co. The UpJohn Co. Warner-Chilcott UpJohn Co. UpJohn Co. Block Drug Co. Key Pharm. Inc. M. Friedland Sandoz Pharmaceuticals Div. Of Sandoz-Wander R. Schiffman Co. LaMay’s Asthmaeze, Inc. F & F Laboratories, Inc. E.R. Squibb & Sons, Inc. Reid Provident Labs. Templetons Incorp. Holford Co. FDA

Dimetane Elixir (Brompheniramine) Pyrroxate Cap. And Tablets Tedral Tedral Anti-H Tedral susp. Emeracol Terpin Hydrate and Codeine Elixir BC All Clear Key Tusscapine Fiogesic Tablets Astmandor LaMay’s Asthmaeze F & F Cough Lozenge Spec-T Lozenges Reidacol Histelet Syrup, Histalet DM Syrup, PV tussin, Tusstrol, tusotrol DM, Coton Syrup RAZ-MAH Greys Capsules Holfords Inhaler, Indian Chief Inhaler Summary of Submissions

Colgate-Palmolive Co. C.H. Costello Penick Henry Thayer Co. UpJohn Co. UpJohn Co. UpJohn Co. UpJohn Co. J.A. Jacob, M.D. Parke Davis & Co. Federal Register 18471 Nat’l Analysts Inc.

Congestaid RM Vaporizer

Glyceryl Guaiacolate Thayers Slippery Elm Throat Lozenges Hydriodic Acid Iodized Lime Special Formula #2 Cedicol (Cough Syrup), Orange Benylin Revocation of Codeine Rx exemption Summary of Health Practices

040227 040228 040229 040230 040231 040232 040433 040434 040235 040236 040237 040238 040239 040240 040241 040242 040243 040244 040245 040246 040247 040248 040249 040250 040251 040251A 040252 040253 040254

Parke-Davis Schering Co. E.R. Squibb & Sons Inc. Sterling Drug, Co. Vicks Chemical Co. Schering/Amendment Smith Kline & French Smith Kline & French Creomulsion Co. V.O. Rankin Lilly Research Labs. Chesebrough-Ponds Bristol-Myers Smith Kline & French Cheston Simmons Pfizer Pharmaceuticals Pfizer Pharmaceuticals Michael A. Hospador Menley & James Labs. Thomas W. Richards E.R. Squibb & Sons Charles L. Kroll Warner/Chilcott Chris P. Katsampes, M.D. Smith Kline & French Cheston Simmons Sterling Drug, Inc. B.G. Crouch, Ph.D. Chesebrough-Ponds Murry Berdick, Ph.D. Merck Sharp & Dohme M. Jane Howell, M.D. Merck Sharp & Dohme M. Jane Howell, M.D. Bristol-Myers Co. Vick Division Research Bob West, Ph.D. Vick Division Research Bob West, Ph.D. Vick Division Research Smith Kline & French Cheston Simmons Sterling Drug, Inc.

Benylin Expectorant Afrin Supplement Spect-T Throat Spray Spec-T Anesthetic Lozenge Addition to Neo-Snyephrine Inhaler Chlor-Trimeton Clorpheniramine Phenylpropanolamine Beechwood Creosote Published articles re: Histadyl, methapyriline hydrochloride Additional information on Pertussin Med. Vapor Safety of Sympathomimetic Drugs in Children 3-6 years Caramiphen Edisylate Toclase Syrup Toclase Tablets Contac Spec-T Anesthetic Lozenges (New Formula-Revised) Tedral Ornacol Liquid and Capsules Thenfadil Pertussin Wild Berry Cough Syrup Sucrets Sucrets Nasel Decongestant Properties of Phenylpropanolamine Concomitancy of Colds Symptoms Patient Reports Topical Ephedrine Benzedrex Inhaler Study Breacol

040255 040256 040257 040258 040259 040260 to 040263 040264 040265 040266 to 040271 040272 040273 040274 040275 040276 040277 to 040278 040279 040280 040281 to 040283 040284 040285 040286 040287 040287A 040288A 040288B 040289 040290

Vick Division Research Bob West, Ph.D. UpJohn Co. Vick Division Research Bob West, Ph.D. Chattem Drug & Chem. Co. J.M. Holbert, Ph.D. Smith Kline & French Wyeth Labs. Wm. L. Langeland Vick Chemical Co. Bob West, Ph.D. Parke-Davis L.M. Lueck Vicks Division Research John B. Ward Smith Kline & French Cheston Simmon Miles Labs. Alfred S. Neely, IV Richardson-Merrell George Hoffnagle, M.D. A.H. Robins F.A. Clark, Jr. UpJohn Co. Jay A. Nadel, M.D. Warner-Lambert Co. Richard C. Brogle Vick/Richardson Merrell A.H. Robins F.A. Clark Hoffman-LaRoche David Winer Ciba-Geigy Edward C. McKeen, M.D. Miles Labs. Richard Shupack Wyeth Labs. Dr. D. Shaw Proprietary Association Proprietary Association Whitehall Labs. Swenson/Behrman Creomulsion Company V.O. Rankin Vicks Division Research

Supplemental - Formula 44 Bronchodilators in Cough Vicks Cough Drops Theophylline sodium glycinate Caramiphen Edisylate Phenergan Doxylamine (Decapryn) as an Antihistamine Proposed study plan for Diphenhydramine Hydrochloride Pseudoephedrine Hydro. Vaposteam Propylhexedrine Phenylpropanolamine Doxylamine Succinate Robitussin The Role of Bronchodilators in CCABA Products Safety and Efficacy Review of OTC CCABA Products, Listerine Antiseptic Oil of Turpentine Suppl. Subm. To Clinical report of GG Robitussin Phenindomine tartrate (Thephorin - Roche) Otrivin (xylometazoline) (hydrochloride NF) Nasal Solution and Spray Three Clinical Salts of Phenylpropanolamine Antihistaminic Effectiveness of Promethazine Supplemental Data on Combinations on the Market Data on Combinations on the Market Phenylephrine and Phenindamine Creomulsion Cough Medicine Ephedrine as Intranasal Decongestant

040291 040292 040293 040294 040295 040296 040297 040298 040299A 040299B 040300 040301 040302 040303 040304 040305 040306 to 040315 040316 040317 040318 040319 040320 040321 040322 040323A 040323B 040324 040325 040326

Vicks Division Research G. F. Hoffnagle Smith Kline & french Arthur L. Davis Pennwalt Corp. A. Lee Caldwell Smith Kline & French Phiip Tannebaum Vick Division Reasearch G. F. Hoffnagle Vick Division Research G. F. Hoffnagle Vick Division Research G. F. Hoffmangle OTC Volume for References Parke-Davis Bristol-Myers Wyeth Labs./AMHO Hoffman-LaRoche Proprietary Association Health Research Group Pennwalt Corp. Vick/Richardson Merrell Hoffman-LaRoche Schiffman AMHO/Wyeth Wyeth Labs. Parke-Davis Parke-Davis Vick Division Research FDA FDA Wyeth Labs. FDA Parke-Davis L. M. Lueck

Literature on Xylometazoline Cold, Cough, Allergy Bronchodilator & Anti-asthmatic Drugs Nonprescription drugs Timed Release dosage forms Caramiphene dislyate dosage Propylhexedrine Category I combinations Alcohol Vicks NYQUIL Combinations approval Vicks Nyquil Antitussive with Antihistamine Vicks Formula 44 Cough Mixture Unpublished data, Memos and Letters Presentation on Benylin Concerning Combo. Policy Concomitance of Symptoms: Rhinorrhea & Cough Activity of Commercial Anthistamines by an In Vivo Evaluation Method Antihistamine Animal Tests Combo. Policy Presentation regarding Timed Release Dosage Forms Supplement to Doxylamine succinate/Nov. 1974 Phenindamine (thephorin) Asthmador Promethazine for allergy and in combo with Antitussive Promethazine adverse Reactions Benadryl/Antitussive Benadryl/Antitussive Appendix A Supplement to Vick Inhaler Desi Reports Desi Reports Effectiveness of Promethazine Epidemiology Antihistamine Toxline Search Benylin Cough Syrup (Benylin Expectorant)

040327 040328 040329 040330 040331 040332

UpJohn Co. A. H. Robins Vick Division Research Vick Division Research Wyeth Labs. Daniel L. Shaw Smith Kline & French Cheston Simmons

Bronchodilators in Cough/Nadel Brompheniramine maleate Antitussive, Analgesic-Antipyretic and Decongestant Supplement to Vicks Nyquil submission Promethazine hydrochloride (Phenergan) Summary of data to support the drying action of antihistamines when prescribed for acute coryza (common cold) for relieve of CCABA Panel Thonzylamine (Neohetramine) and Phenyltoloxamine Warner Lambert Co. Products Comments concerning dosage of specified dosage forms Self-medication Nasal decongestants Naphazoline & Xylometazoline Report on Carcinogenicity Antitussives (noscapine) Diphenhydramine Diphenhydramine Statement on DTC Cough/Colds principles applicable to combo. drugs

040333 040334 040335 040336 040337 040338 040339 040340 040341 040342

Warner-Lambert Co. Richard C. Brogle Warner-Lambert Co. Richard C. Brogle Vick Division Research Vick Division Research Ciba-Geigy Edward C. McKeon NCI Study on Chloroform Fisons Corp. Parke-Davis Parke-Davis Vick Chemical

TFM VOLUME: 04BTFM Has been established for Bronchodilator Drug Products

TFM VOLUME: 04CTFM has been established for Anticholinergia Drug Products

TFM VOLUME: 04HTFM Has been established for Antihistamine Drug Products

TFM VOLUME: 04NTFM Has been established for Nasal Decongestant Drug Products

OTC SEDATIVES, TRANQUILIZERS AND SLEEP AIDS REVIEW PANEL INDEX TO DATA SUBMISSIONS
VOLUME NUMBER 050001 050002 SUBMITTED BY Monsanto Co. FDA (Portland Retail Druggist Association) TRADE NAME None None INGREDIENTS Methapyrilene HCl Methapyrilene Fumarate Miscellaneous Documents from FDA files - Originally Submitted to DESI Study Scopolamine Aminoxide HBr. Methapyrilene HCl Salicylamide Scopolamine Aminoxide Hbr Methapyrilene Hcl Salicylamide Acetaminophen Aspirin Methapyrilene Hcl Scopolamine Hbr. Methapyrilene HCl Scopolamine HBr REMARKS Bulk Chemical Bulk Chemical

050003 (Box A) 050004 (Box B) 050005

J. B. Williams Co.

Sominex Tablets

Submitted loose in boxes at Firms request

Sominex Tablets

Whitehall Labs. Inc.

Quiet World

050006

Whitehall Labs.

Sleep-eze

050007

Block Drug Co.

Nytol Tablets Nytol Capsules

Methapyrilene HCl Scopolamine HBr Methapyrilene HCl Salicylamide Pyrilamine maleate Methapyrilene HCl Scopolamine aminoxide HBr. Selected articles and papers FDA Library Search Abstracts A Study of Health Practices and Opinions Final Report FDA Contract No. 66-193, June, 1972 Drug Efficacy Study (NAS?NRC) Reports only one drug was covered, DORMIN

050008 050009 050010 050011 050012

Jeffrey Martin Inc.

Compoz Tablets

FDA (Dr. Chernov) FDA (Medical Library) FDA (OTC Staff)

050013

FDA (OTC Staff)

Methapyrilene HCL

050014 050016

Miles Labs. FDA (Dr. Chernov)

Miles Nervine

Sodium bromide Potassium bromide Ammonium bromide Scopolamine

050017

FDA (Medical Library)

Salicylamide

050018

Dr. Hartmann

050019

Jeffrey martin Inc.

Compoz Tablets

050020 050021

Jeffrey Martin Inc. J. B. Williams Co.

Compoz Tablets

050022 050023 050024

Miles labs. Bristol-Myers

None Excedrin P.M.

Diphenhydramine Hydrochloride Aspirin Salicylamide Acetaminophen Methapyrilene furmarate

Paper titled “Proprietary Hallucinogens” by Leff and Bernstein Limited literature search and bibliography on Salicylamide with selected articles Selected Papers by Dr. Hartmann submitted to the other Panel members at his request Amendment to previous submission (050008) “Appropriate and Inappropriate Methodology in the evaluation of OTC Daytime Sedatives (More legible copy of Submission No. 050009) Data on sedative properties of DOXYLAMINE and PHENYLTOLOXAMI NE Data on the use of this agent as a sedativesleep aid

050025

FDA

050026 050027 050028 050029 050030 050031

Miles Labs. Bristol-Myers Parke Davis Dr. Norris FDA Endo. Labs.

None

Diphenhydramine Hydrochloride

Adverse Reactions Data on Bromides, Scopolamino Compoz and Sominex requested by Panel Additional data submitted at Panel’s request Additional data on Methapyrilene/Excedri n P.M. Toxicity Data Labeling information request by Panel

Bendryl Diphenhybromide

Percogesic Dilone

Acetaminophen Phenyltoloxamine acetate Caffeine Additional Data Additional Data Additional Submission (Excedrin P.M.) Benadryl Comments on Daytime Sedatives Additional data Additional information on percogesic Study plan for Diphenhydramine Additional comments on Dr. Rickels study of Compoz Additional data Data requestred by Panel

050032 050033 050034 050035 050036 050037 050038 050039 050040 050041 050042 050043 050044

Bristol-Myers Bristol-Myers Bristol-Myers Parke Davis Jeffrey Martin Parke Davis Endo Labs. Parke Davis J.B. Williams Whitehall Labs. Division of American Home Products Whitehall Labs. Division of American Home Products Sedative Panel Working Papers Del Labs. Inc. Parmingdale, N.Y.

Excedrin P.M. Excedrin P.M. Excedrin P.M.

Compoz Diphenhydramine (Bendryl)

Diphenhydramine Diphenhydramine

Placin Calmative Capsules

Paminobenzoic Acid Salicylamide Passiflora (Passion Flower) P.E. Euphorbia P.E. Safety data on talc Target population for Daytime Sadatives Comments on Doxylamine Succinate Hypnotic Testing guidelines

050045 050046 050047 050048

Johnson & Johnson Co. New Brunswick, N.J. American Home Products Corp. Lemming-Pacquin FDA

050049

050050

050051

050052

050053 050054 050055

Scopolamine Scopolamine Miscellaneous

Referenences Nighttime Sleep-Aids, Daytime Sedatives, Stimulants A-E References Nighttime Sleep-Aids, Daytime Sedatives, Stimulants F -K References Nighttime Sleep-Aids, Daytime Sedatives, Stimulants L-R References Nighttime Sleep-Aids, Daytime Sedatives, Stimulants S-Z References - (uncited) References - (uncited) References - (uncited)

PUBLIC ADMINISTRATIVE FILE Sunscreen Volumes

VOLUME 060001 060002 060003 060004 060005 060010 060018 060019 060021

COMPANY Texas Pharmacal “ “ “ Felton Chemical Co. Van Dyck & Co., Inc. “ “ Givaudan Corporation

SUBJECT A-Fil Cream Sundare Creamy Lotion Sundare Clear Lotion Sun Stick Lip Protectant Suncreme Concentrate WMO Escalol 507 Escalol 508 Escalol 106 Giv-Tan F

060037 060044 060057 060064 060065 060066 060067 060069 060070 060072 060076 060081 060083 060084 060086 060088 060089 060090 060091 060093 060103 060104 060105 060110 060115 060116 060117 060120 060125 060128 060129 060130 060131 060134 060135

Menley & James Labs Texas Phar. Westwood Pharm., Inc. Plough, Inc. “ ” “ Rowell Labs, Inc. Plough, Inc. “ Lanvin - Charles of the Ritz Westwood Pham. greiter Corp. Int. Amerchol E. M. Labs Felton Chem. Co. Haarman & Reimer Corp. E. M. Labs Bonne Bell Inc. E. M. Labs G. S. Herbert Labs “ Amerchol Givaudan Corp. E. M. Labs Miles Labs Chattem Labs Elizabeth Arden Inc. Texas Pharmacal Co. GAF Corp. Hill Top Research Greiter Corp. Plough, Inc. Scher Chemical Plough, Inc.

Sea and Skin Golden Tan Sun Swept Cream PreSun Lotion Coppertone, etc. “ Sudden Tan QT Foam Doushield Two, One Sunshielding Lotion Sun Protective Foam Ravenescence, etc. Presun, additional Piz Buin, etc. Amerscreen P Eusolex, etc. Sunarome Conc. Neo Heliopan AV Eusolex - additional data Triethanolamine salicylate Eusolex 3573 - additional data Eclipse Amerscreen P Parsol MX, Parsol Hydro Eusolex 6300 Sunguard Alpaba Sun Gelee A-Fil - additional data Technical information Sunscreens Additional data Additional data Dipsal Sun Protective Lotion

060143 060145 060147 060148 060151 060154 060155 060157 060158 060159 060162 060163 060164 060165 060166 060167 060168 060169 060170 060171 060175 060176 060177 060182 060183 060185

Greiter Corp. Van Dyck Schuylkill Chem. Co. Westwood Pharm. Felton Int. Paul B. Elder PA/CTFA comment on sunscreens Greiter Hill Top Johnson & Johnson Givaudan Elizabeth Arden Plough, Inc. AVA, Inc. Westwood “ Johnson & Johnson CTFA/PA Plough Ingram Pharm. Co. Westwood Johnson & Johnson Dome Labs References, Cited References, Uncited References, Cited--Measurements of UV Radiation in the US and Comparisons with Skin Cancer Data

UV Filters Additional data Alpaba - additional data Presun - additional data Sunarome RVP with Magnasurf

Additional data Comments Testing Parsol MCX Suncare Line Testing Aloe Vera Gel for Sun, Vehicles Label comments Protocol for tests Comparative tests Skin cancer data UV absorber 3 Comments on sunscreen draft “ ”

Panel Administrator’s File (Correspondence File), Volume I Panel Administrator’s File (Correspondence File), Volume II Minutes of the OTC Panel on Topical Analgesic, Antirheumatic, Otic, Burn, and Sunburn Treatment and Prevention Drug Products

Skin Protectants VOLUME 060007-A 060011 060034 060065 (see sunscreen vols) 060080-B 060109 060112 060113 060114 060123-A COMPANY E. R. Squibb Gebauer Chem. Co. Church & Dwight Co., Inc. Plough, Inc. Calhoun’s Lab. Chesebrough-Pond’s Inc. Whitehall Labs., Inc. Whitehall Labs., Inc. Whitehall Labs., Inc. Bowman Pharm., Inc. SUBJECT Zinc Oxide Ointment Gebauer’s Tannic Spray Sodium bicarbonate Coppertone Lip Balm Burn-O-Jel Vaseline Sperti Healing Ointment Digene Chafing Ointment Digene Chafling Ointment Almophen Ointment Calamine Compound Easte Caloxol Lotion Petrozine Ointment Mexsana Medicated Powder Additional SRF data Obtundia Calamine Cream Additional SRF data Dimethicone

060137 060149 060152 060160 060172

Plough, Inc. American Home Products Co. Otis Clapp & Sons American Home Products Co. Plough, Inc.

ADMINISTRATIVE FILE

Skin Protectant Drug Products for OTC Human Use Establishment of a Monograph and Reopening of Administrative Record Docket No. 78N-0021 Volume 06DPA2 In the FEDERAL REGISTER of September 7, 1982 (47 FR 39436), the administrative record for the OTC skin protectant drug products rulemaking was reopened to include 5 statements by the Advisory Review Panel on OTC Miscellaneous External Drug Products. To avoid duplication, the Public administrative file for the OTC external Analgesic Drug Products rulemaking (Docket No. 78N-0301) that was also reopened on September 7, 1982 (47 FR 39412). The name of each statement included in the skin protectant rulemaking and its corresponding volume number in the external analgesic administrative file appears below. Statement OTC Drug Products for the Treatment of Diaper Rash OTC Drug Products for the Prevention of Poison Ivy, Oak, and Sumac OTC Drug Products for the Treatment of Fever Blisters OTC Astringent Drug Products Volume No. 06BPA6 06BPA7 06BPA8 06BPA10

OTC Insect Bite Neutralizer Drug Products

06BPA11

PUBLIC ADMINISTRATIVE FILE OTC EXTERNAL ANALGESIC DRUG PRODUCTS Docket No. 78N-0301
VOLUME 060005* 060007-B 060008 060009 060011 060012 060013 060014 060015 060016 060017 060017 060017 060017 060017 060020 060022 060023 060024 060025 SUBMITTED BY Monsanto Industrial Chem. Co. E.R. Squibb & Sons, Inc. Wm. P. Poythress Yager Drug Co. Gebauer Chemical Co. Ciba-Geigy, Inc. Ciba-Geigy, Inc. Brown Medicine Co. Carbisulphoil Co. Carbisulphoil Co. C. G. Smith Products Co. Geriatric Pharm Co. Wade Chemical Corp. Berry & Withington Co. Meyer Brothers Drug Co. Astra Pharm. Products Inc. The Mentholatum Co. The Mentholatum Co. Warren-Teed Pharm., Inc. The Dow Chemical Co. SUBJECT Methyl salicylate Counterpain Rub Panalgesic Yager’s Liniment Gebauer’s Tannic Spray Nupercainal Cream, etc. Nupercainal Cream, etc. Brown’s N & B Liniment Foille Liquid & Ointment Foille Liquid & Ointment Gypsy Rub Liniment Ger-O-Foam Jim Wade Deep Treet Liniment Analgesic Balm Bet-U-Lol Xylocaine Ointment Mentholatum Deep Heating Lotion Mentholatum Deep Heating Rub Myoflex Cream Creme Dyclone

060026

Smith, Kline & French Labs

Quotane Lotion, etc.

* Sequential volume numbers not on this list are already on file with the Hearing Clerk, as follows: OTC Topical Otic Drug Products, Docket No. 77N-0334, OTC Skin Protectant Drug Products, Docket No. 78N-0021, OTC Sunscreen Drug Products, Docket No. 78N-0038

VOLUME 060027 060029 060030 060031 060032 060033 060035 060036 060038 060039 060040 060041 060042 060043 060045 060046 060047 060048 060049 060050 060051 060052 060053 060054

SUBMITTED BY Whitehall Labs, Inc. Whitehall Labs, Inc. Whitehall Labs, Inc. Whitehall Labs, Inc. Whitehall Labs, Inc. Whitehall Labs, Inc. W. F. Young, Inc. W. F. Young, Inc. Resinol Chemical Co. Abbott Labs Warner-Lambert Research Institute Norwich Pharmacal Co. Norwich Pharmacal Co. Norwich Pharmacal Co. Abbott Labs Pfizer, Inc. Sterling Drug, Inc. Sterling Drug, Inc. Sterling Drug, Inc. Denver Chemical Mfg. Co. Plough, Inc. Denver Chemical Mfg. Co. Sterling Drug, Inc. Denver Chemical Mfg. Co.

SUBJECT Outgro Instant Heet Spray Heet Analgesic Liniment Heet Gel Anbesol Infrarub Asborbine, Jr. Absorbine Arthritic Pain Lotion Resinol Ointment, Cream Butesin Picrate Ointment Sloan’s Liniment, Balm Unquentine Aerosol Unquentine Ointment Unquentine Plus Tronothane HCl Un-Burn Pontocaine Cream Pontocaine Ointment Medi-Quick Dencorub Musterole Antiphlogistine Campho-Phenique Pain Away

060055 060056 060058 060059 060060 060061 060062 060063 060068 060071 060073 060074 060075 060077 060080-B 060082 060085 060087 060092 060094 060095 060096 060097 060098 060099 060100 060101 060102 060106 060107 060108 060111

Plough, Inc. Pfizer, Inc. Combe, Inc. Combe, Inc. Combe, Inc. Medical Supply Co. Quist Chemical Co. Enegoltaria Medicine Co. Ciba Pharmaceutical Co. Plough, Inc. Arnar-Stone Labs, Inc. The R. Schattner Co. Sperti Drug Products Block Drug Co., Inc. Calhoun’s Laboratory M. S. Glorius Co. Noxell Corp. W. F. Young, Inc. Whitehall Labs, Inc. Carbisulphil Co. Parke, Davis & Co. Noxell Corp. Plough, Inc. Plough, Inc. Plough, Inc. Plough, Inc. Plough, Inc. Plough, Inc. Ciba-Geigy, Inc. Ciba-Geigy, Inc. Ciba-Geigy, Inc. Plough, Inc.

Solarcaine Cream, etc. Ben-Gay Ointment - Lotion Lanacane Spray Soak’n Massage Lanacane Cream MSCo Burn Compound, etc. A’MAY’S-On Ointment Linimento Daire, etc. Pyribenzamine Cream, etc. Dermasol Cream, Foam, Lotion Americaine Sun Balm, etc. Oraderm, etc Aspercreme Omega Oil Burn-O-Jel Glourius Pain Relief Noxzema Skin Cream Absorbine Jr.-additional data Infrarub-additional data 8-hydroxyquinoline Benadryl, etc. Noxzema-additional data Hydrocortisone preparations Hydrocortisone preparations Hydrocortisone preparations Hydrocortisone preparations Hydrocortisone preparations Hydrocortisone preparations Vioform-Hydrocortisone Vioform-Hydrocortisone Vioform-Hydrocortisone Musterole, etc.

060118 060119 060121 060122 060123-B 060124 060126 060127 060132 060133 060136 060138 060139 060140 060141 060142 060144 060146 060150 060152 060153 060156 060161 060173 060174 060178 060179 060180 060186 060187

C. F. Kirk Labs Rexall Drug Co. C. F. Kirk Labs Dermik Labs Bowman Pharm., Inc.

Exocaine-additional data Thru, Intracel Exocaine-additional data Hydrocoortisone comments Liquid Analgesic, etc.

American Academy of Dermatology Report on Hydrocortisone C. F. Kirk Labs Pfizer, Inc. C. F. Kirk Labs Reed & Carnrick Pharmaceuticals C. F. Kirk Labs Beecham Products (formerly Calgon) Beecham Products (formerly Calgon) Beecham Products (formerly Calgon) Eli Lilly & Co. Eli Lilly & Co. Warren-Teed Pharm., Inc. Sterling Drug, Inc. Miscellaneous submissions to the Panel Otic Clapp & Sons Carol Angle, M.D. B. F. Ascher & Co. The Upjohn Co. W. F. Young, Inc. W. F. Young, Inc. FDA Arnar-Stone Labs, Inc. American Home Products Exocaine-additional data Ben-Gay-additional data Additional data Tarcortin Additional data S.T. 37 S.T. 37 S.T. 37 Surfadil Surfacaine Myoflex-additional data Additional data

Obtundia, etc. Comment on camphor Mobisyl Creme Hydrocortisone literature Absorbine Jr.-Supplement Absorbine Jr.-Supplement Hydrocortisone data search-viral infections Presentation to Panel on methemoglobinemia and benzocaine Statement to the Panel References cited in report A-C References cited in report D

060188 060189 060190 060191 060192 060193 060194 060195 060196 060197 060198 060199 060202 060203 060204 06BPA1 06BPA2 06BPA3 06BPA4 06BPA5 Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Panel Administrator’s File, Volume I - General Panel Administrator’s File, Volume II - Meeting Summary Minutes Panel Administrator’s File, Volume III - Correspondence File (1972, 1973) Panel Administrator’s File, Volume IV - Correspondence File (1974, 1975) Panel Administrator’s File, Volume V - Correspondence File ( 1976, 1980)

References cited in report E-G References cited in report H-L References cited in report M-P References cited in report Q-S References cited in report T-Z References evaluated but not cited in report A-B References evaluated but not cited in report C-D References evaluated but not cited in report E-G References evaluated but not cited in report H-L References evaluated but not cited in report M-R References evaluated but not cited in report S-Z Abstracts of Bibliography - Topical Analgesic ingredients Cort-Dome Hydrocortisone Cort-Dome Hydrocortisone Cort-Dome Hydrocortisone

ADMINISTRATIVE FILE External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record Published in the FEDERAL REGISTER on September 7, 1982 (47 FR 39412)

Part I Statement on OTC Drug Products For the Treatment of Diaper Rash Docket No. 78N-0301 Panel Administrator’s File
VOLUME 06BPA6 CONTENTS 1.1 1.2 Call for Data List of Panel Members and Liaisons

1.3 Curriculum Vitae of Panel Memebers and Liaisons 1.4 General Charge to Panel 1.5 1.6 1.7 1.8 1.9 Index to Panel Submissions Minutes of Panel Meetings Correspondence Cited References Uncited References

External Analgesic Drug Products for OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Drug Products for the Prevention of Poison Ivy, Oak, and Sumac Part II Docket No. 78N-0301 Index to OTC Volumes
VOLUME NO. SUBMITTED BY PRODUCT

160074 160103 160132 160152

Marion Health and Safety, Inc. Unimed, Inc. Marion Health and Safety, Inc. Marion Health and Safety, Inc.

Poison Ivy Wash Residerm (Poison Ivy Lotion) Zircreme, Ferric Chloride, StingKill Poison Ivy Wash

ADMINISTRATIVE FILE External Analgesic Drug Products for OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record Published in the FEDERAL REGISTER on September 7, 1982 (47 FR 39412) Part II Statement on OTC Drug Products for the Prevention of Poison Ivy, Oak, and Sumac Docket No. 78N-0301

Panel Administrator’s File
VOLUME 06BPA7 CONTENTS 1.1 1.2 Call for Data List of Panel Members and Liaisons

1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 1.6 Index to Panel Submissions Minutes of Panel Meetings

1.7 Correspondence 1.8. References

External Analgesic Drug Products for OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Drug Products for the Treatment of Fever Blisters Part III Docket No. 78N-0301 Index to OTC Volumes
VOLUME NO. 160008 160012 160013 160048 SUBMITTED BY Commerce Drug Co., Inc. Commerce Drug Co., Inc. Commerce Drug Co., Inc. Campbell Laboratories, Inc. PRODUCT Bio-Stik Tanac Tanac Stik Herpecin-L

160096 160136 160177 160197 160213 160218 160231

Blistex, Inc. Sterling Drug Inc. International Pharmaceutical Corp. Oral Prophylactic Assoc., Inc. Blistex, Inc. Glenbrook Laboratories Sterling Drug, Inc.

Blistex Ointment Campo-Phenique Gly-Oxide Liquid Mouth Komfort Blistik Lip Balm Campho-Phenique Campho-Phenique

ADMINISTRATIVE FILE External Analgesic Drug Products For OTC Human Use; Establishement of a Monograph and Reopening of Administrative Record Published in the FEDERAL REGISTER on September 7, 1982 (47 FR 39412) Part III Statement on OTC Drug Products For the Treatment of Fever Blisters Docket No. 78N-0301

Panel Administrator’s File
VOLUME 06BPA8 CONTENTS 1.1 1.2 Call for Data List of Panel Members and Liaisons

1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 1.6 1.7 1.8 Index to Panel Submissions Minutes of Panel Meetings Correspondence References

External Analgesic Drug Products for OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Male Genital Desensitizing Drug Products Part IV Docket No. 78N-0301 Index to OTC Volumes
VOLUME 160001 160014 160171 SUBMITTED BY Frederick Damrau, M.D. Commerce Drug Co., Inc. Ciba-Geigy Corp. PRODUCT Culminal Detane Nupercainal Ointment

160260 160266 160281 160290 160388 06BPA9-A 06BPA9-B

Keller and Heckman for Pound International Corp. Keller and Heckman for Pound International Corp. Del laboratories Commerce Drug Co., Inc. Del Laboratories

Stud-100 Stud-100 Detane Detane Detane Cited References Uncited References

ADMINISTRATIVE FILE External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record Published in the FEDERAL REGISTER on September 7, 1982 (47 FR 39412) Part IV Statement on OTC Male Genital Desensitizing Drug Products Docket No. 78N-0301 Panel Administrator’s File
VOLUME CONTENTS

06BPA9

1.1 1.2

Call for Data List of Panel Members and Liaisons

1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 1.6 1.7 Index to Panel submissions Minutes of Panel Meetings Correspondence

External Analgesic Drug Products for OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Astringent Drug Products Part V Docket No. 78N-0301 Index to OTC Volumes
VOLUMES NO. 160022 160038 160039 160069 SUBMITTED BY Marion Laboratories Inc. Dome Laboratories Dome Laboratories Cooper Laboratories, Inc. MARKETED PRODUCTS /SUBJECT Bluboro Powder Acid Mantle, Creme, Lotion Domeboro Tablets, Powder Acnaveen Bar, Cream, Aveeno Bar, Bath, Oilated Bath, Avenol Bath Additive, Bur-Veen Wet Dressing Powder, Emulave Bar, Nixoderm Ointment, Packers Pine Tar Shampoo, Soap, Sebaveen Shampoo

160070

Cooper Laboratories, Inc.

160093 160140 160219 160230 160233 160354 160396 160409 160413 160428 160429 160433 160435 06BPA10-A 06BPA10-B

R. L. Gaddy Co. Marion Laboratories, Inc. Marion Laboratories, Inc. Marion Laboratories, Inc. Cox Drugs Humpheys Pharmacal, Inc. Stiefel Research Institute, Inc. Perito, Duerk, Carlson & Pinco for Requa Manufacturing Co., Inc. The Woltra Company, Inc. The E. E. Dickinson Co. Beecham Products American Distilling and Manufacturing Co., inc. Requa Manufacturing Co., Inc.

Acnaveen Bar, Cream, Aveeno Bar, Bath, Oilated Bath, Avenol Bath Additive, Bur Veen Wet Dressing Powder, Emulave Bar, Nixoderm Ointment, Packers Pine Tar Shampoo, Soap, Sebaveen Shampoo Ez-It Medicted Foot Powder Bluboro Powder Bluboro Powder Bluboro Powder Formula “U” Witch Hazel AluWets Aluminum Sulfate Styptic Pencil Aluminum Sulfate Styptic Pencil Witch Hazel OTC Astringent Vaginal Douche Drug Products Witch Hazel Study Aluminum Sulfate Cited References Uncited References

ADMINISTRATIVE FILE External Analgesic Drug Products for OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record Published in the FEDERAL REGISTER on September 7, 1982 (47 FR 39412)
Part V Statement on OTC Astringent Drug Products Docket No. 78N-0301 Panel Administrator’s File VOLUME 06BPA10 CONTENTS 1.1 1.2 Call for Data List of Panel Members and Liaisons

1.3 Curriculum Vitae of panel Members and Liaisons 1.4 General Charge to Panel 1.5 1.6 1.7 Index to Panel Submissions Minutes of Panel Meetings Correspondence

External Analgesic Drug Products for OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Insect Bite Neutralizer Drug Products Part VI Docket No. 78N-0301 Index to OTC Volumes
VOLUME NO. 160074 160119 160132 160159 160434 SUBMITTED BY Marion Health and Safety, Inc. Tender Corp. Marion Health and Safety, Inc. Marion Health and Safety, Inc. Tender Corp. PRODUCT Sting Kill Swabs After Bite Sting Kill Swabs Sting Kill Swabs After Bite

ADMINISTRATIVE FILE External Analgesic Drug Products for OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record Published in the FEDERAL REGISTER on September 7, 1982 (47FR 39412) Part VI Statement on OTC Insect Bite Neutralizer Drug Products Docket No. 78N-0301 Panel Administrator’s File
VOLUME 06BPA11 CONTENTS 1.1 1.2 Call for Data List of Panel Members and Liaisons

1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 1.6 1.7 1.8 Index to Panel Submissions Minutes of Panel Submissions Correspondence References

ADMINISTRATIVE FILE

Skin Protectant Drug Products for OTC Human Use Establishment of a Monograph and Reopening of Administrative Record Docket No. 78N-0021 Volume 06DPA2 In the FEDERAL REGISTER of September 7, 1982 (47 FR 39436), the administrative record for the OTC skin protectant drug products rulemaking was opened to include 5 statements by the Advisory Review Panel on OTC Miscellaneous External Drug Products. To avoid duplication, the Public Administrative File for these 5 statements appears as parts of the administrative file for the OTC external analgesic drug products rulemaking (Docket No. 78N-0301) that was also reopened on September 7, 1982 (47 FR 39412). The name of each statement included in the skin protectant rulemaking and its corresponding volume number in the external analgesic administrative file appears below.
STATEMENT OTC Drug Products for the Treatment of Diaper Rash OTC Drug Products for the Prevention of Poison Ivy, Oak, and Sumac OTC Drug Products for the Treatment of Fever Blisters OTC Astringent Drug Products OTC Insect Bite Neutralizer Drug Products VOLUME NO. 06BPA6 06BPA7 06BPA8 06BPA10 06BPA11

TFM VOLUME 060TFM Has been established for Topical Otic Drug Products

TFM VOLUME 06BTFM Has been established for EXTERNAL ANALGESIC

DRUG PRODUCTS PART OF TOPICAL ANALGESIC

TFM VOLUME 06DTFM Has been established for Skin Protectant Drug Products

Docket No. 80N-0476 PUBLIC ADMINISTRATIVE FILE TOPICAL ANTIFUNGAL VOLUMES
VOLUME 070001 COMPANY Wade Chemical Corp. PRODUCT OR SUBJECT Jim Wade Foot Powder

070004 070008 070010 070017 070018 070019 070020 070022 070024-25 070029 070032 070033 070034 070042 070043 070045 070057 070058 070065 070066 070068 070085 070087 070095 070100 070101 070107 070108 070134

Laboratory Robaina, Inc. Givaudan Corp. Schering Corp. Norwich Pharmacal Co. Norwich Pharmacal Co. Norwich Pharmacal Co. Norwich Pharmacal Co. Pennwalt Corp. Pennwalt Corp. Pennwalt Corp. Wyeth Laboratories, Inc. Dermik Laboratories, Inc. William H. Rorer, Inc. W.F. Young, Inc. W.F. Young, Inc. La Wall & Harrisson, Inc. Upjohn Co. Upjohn Co. R.L. Gaddy Red Foot Products Ciba-Geigy Corp. Texas Pharmacal Co. Ayerst Laboratories U.S. Borax Schuylkill Chemical Co. R. Schattner Co. Magnesia Products, Inc. Smith, Kline & French Laboratories Chattem Drug & Chemical Co.

Acetolia Robaina G-4 (Dichlorophen) Tinactin Cream, Tinactin Powder, Tinactin Powder Aerosol, Tinactin Solution, Tinactin Solution Aerosol NP-27 Cream NP-27 Liquid NP-27 Aerosol NP-27 Powder Cruex Medicated Spray-On Powder Desenex Ointment, Desenex Powder, Desenex Solution, Desenex Spray-On Powder Cruex Medicated Spray-On Powder Sopronol Ointment, Sopronol Powder, Sopronol Solution Two articles on coal tar Carfusin Absorbine Athlete’s Foot Powder Absorbine Jr. Ecco Medicated Powder Medicated Foot Powder Fluid Salicresin Ez-It Red Foot Powder Vioform Cream, Vioform Ointment, Vioform Powder Verdefam Cream, Verdefam Solution Enzactin Aerosol, Enzactin Cream, Enzactin Powder Article on borax and boric acid Articles on alcloxa, allantoins Chloraderm Sporodyne Pragmatar Blis-To-Sol Aerosol Powder, BlisTo-Sol Liquid, Blis-To-Sol Medicated Gel, Blis-To-Sol Powder

070135 070136 070137 070138 070139 070140 070141 070146 070147 070148 070151 070152-4

Scholl, Inc. Scholl, Inc. School, Inc. Scholl, Inc. School, Inc. Carbisulphoil Co. Pennwalt Corp. Rystan Co., Inc. Plough, Inc. Cramer Products, Inc. Cramer Products, Inc. Ciba-Geigy Corp.

Solvex Athlete’s Foot Powder Solvex Athlete’s Foot Spray Powder Solvex Athlete’s Foot Spray Solvex Athlete’s Foot Liquid Solvex Athlete’s Foot Ointment Articles on sulfur Calcium undecylenate/hydrocortisone acetate cream Prophyllin Ointment, Prophyllin Powder Aftate Gel, Aftate Powder, Aftate Spray Liquid, Aftate Spray Powder Fung-O-Spray Cramer Foot Ointment Vioform-Hydrocortisone Cream, Vioform-Hydrocortisone Liquid, Vioform-Hydrocortisone Mild Cream, Vioform-Hydrocortisone Mild Ointment, VioformHydrocortisone Ointment Tinactin Powder, Tinactin Powder Aerosol Desenex Vioform-Hydrocortisone Buderma First Aid Ointment Foot Guard Foot Powder Foot Guard Foot Deodorant Spray Sopronol Verdefam Tolindate Tinactin Cream, Tinactin Powder, Tinactin Powder Aerosol, Tinactin Solution, Tinactin Solution Aerosol Studies on phenol Letter regarding new data on Vioform, Vioform-Hydrocortisone Dichlorophen safety study Resorcinol toxicity studies Talc report

070157 070158 070160 070161 070162 070163-4 070165 070169 070170-1 070177 070178 070179 070180 070182 070183

Schering Corp. Pennwalt Corp. Ciba-Geigy Corp. Buckman Laboratories, Inc. Gillette Co. Gillette Co. Wyeth Laboratories, Inc. Texas Pharmacal Co. Norcliff Thayer Inc. Schering Corp. R. Schattner Co. Ciba-Geigy Corp. Givaudan Corp. Clairol Research Laboratories Johnson & Johnson

070184 070185 070186 070189 070190 070192 070193 070194-5 070196 070197 070198 070200 070201-2 070204 A&B 070208 070209 070210-1 070212 070214 070215 070216 070217 070219 070220-1 070222 070223 070224 070225 070226 070227 070228

Warner-Lambert Co. Johnson & Johnson Otis Clapp & Son, Inc. Pennwalt Corp. W.F. Young, Inc. Otis Clapp & Son, Inc. Ciba-Geigy Corp. Ferro Corp. W.F. Young, Inc. Ferro Corp. Pennwalt Corp. Pennwalt Corp. Reckitt & Colman Johnson & Johnson Pennwalt Corp. Ciba-Geigy Corp. W.F. Young, Inc. Pennwalt Corp. W.F. Young, Inc. Johnson & Johnson Schering Corp. Johnson & Johnson Westwood Pharmaceuticals Inc. U.S. Borax Proprietary Association Johnson & Johnson Proprietary Association Pennwalt Corp. W.F. Young, Inc. Ferro Corp. Richardson-Merrell, Inc.

Review of methyl salicylate safety and effectiveness Article on talc Obtundia Antiseptic Swab Pads, Obtundia First Aid Spray Desenex Absorbine Athlete’s Foot Obtundia Surgical Dressing Vioform, Vioform-Hydrocortisone Chloroxylenol safety and effectiveness Chloroxylenol safety and effectiveness Chloroxylenol Prophylactic efficacy of undecylenic acid Chloroxylenol irritation and sensitization studies Chloroxylenol safety and effectiveness Miconazole nitrate cream Chloroxylenol Vioform, Vioform-Hydrocortisone Absorbine, Jr. Denenex Absorbine, Jr. statistical data Miconazole nitrate labeling claims Tolnaftate/nystatin cream Miconazole nitrate/hydrocortisone cream Halotex Cream, Halotex Solution Literature review on toxicity of boric acid and sodium tetraborate Labeling claims Labeling claims Paper on guinea pig model Paper on fungicidal testing In vivo guinea pig studies Chlorooxylenol in vitro data Resorcinol safety

070229 070231 070232 070233 070237 070240 070241 070243 070246 070247 070249 070251 070252 070253 070254 070257 070258 070265 070266 070267 070301-307 070308-310 07APA1 07APA2A&B 07APA3

Purdue Frederick Co. Pennwalt Corp. R. Schattner Co. Ciba-Geigy Corp. Westwood Corp. Schering Corp. R. Schattner Co. Purdue Frederick Co. Rilox Co. Sterling Drug, Inc. Sterling Drug, Inc. Stiefel Laboratories, Inc. Schering Corp. Sterol Controls Co. Westwood Pharmaceuticals, Inc. Schering Corp. Purdue Frederick Co. Ciba-Geigy Corp. Pennwalt Corp. Wyeth Laboratories Antifungal References, Cited Antifungal References, Uncited Panel Administrator’s File Panel Administrator’s File of panel meetings Panel Administrator’s File, Correspondence File (1978 - 1982)

Isodine Athlete’s Foot Solution Cruex Medicated Cream Letter requesting reclassification of phenol Vioform, Vioform-Hydrocortisone in vitro data Haloprogin Anti-candidal data Summary of tolnaftate safety Letter on phenol Chemistry of povidone-iodine Geneva Ointment Campho-Phenique Liquid Campho-Phenique Liquid, Campho-Phenique Powder Salicylic Acid and Sulfur Soap Tolnaftate Candicidin Halotex Tinactin Povidone-iodine Iodochlorhydroxyquin Comments on antifungal report Caprylate and propionate combinations

Volume I - General Volume II - Minutes Volume IV -

Docket No. 81N-0114 PUBLIC ADMINISTRATIVE FILE TOPICAL ACNE VOLUMES
VOLUME 070002 070004 070005 070006 070009 070022 070030 070036-7 070038-41 070046-47 070048 070053 070056 070060 070070 070071 070072 070073 070083 070086 070088 COMPANY William P. Poythress & Co. Laboratory Robaina, Inc. E.R. Squibb and Sons Miranol Chemical Co., Inc. Preston Pharmaceutics Pennwalt Corp. Campana Corp. Warner Lambert Vick Divisions Research Preston Pharmaceutics USV Pharmaceutical Corp. Upjohn Co. Upjohn Co. Flow Pharmaceuticals Texas Pharmacal Co. Texas Pharmacal Co. Texas Pharmacal Co. sterling Drug, Inc. Sterling Drug, Inc. Texas Pharmacal Co. Barnes-Hind Pharmaceuticals PRODUCT OR SUBJECT Bensulfoid Lotion Acetolia Robaina Epi*Clear Antiseptic Lotion 10% Epi*Clear Antiseptic Lotion 5% Epi*Clear Acne Lotion Miranol C2M Dermakon Dandruff Shampoo Ting Antiseptic Medicated Cream Cuticura (Cutitone) Acne Cream Listerex Antibacterial Acne Scrub Clearasil Regular Tinted, Clearasil Stick Medication, Clearasil Vanishing Formula Dermakon Medicated Cream Oxy-5 Plexion Zinc Sulfide Compound Lotio, Improved d-Seb Sulforcin Lotion Sulforcin Base 4% Liquimat pHisoAc Stri-dex Medicated Pads Contrablem Komed Acne Lotion Komed Mild Acne Lotion

070089 070090 070092 070093 070096 070097-99 070100 070101 070102-4 070105 070106 070109 070113 070124 070126

Westwood Pharmaceuticals Westwood Pharmaceuticals Westwood Pharmaceuticals Westwood Pharmaceuticals Helena Rubinstein, Inc. Texas Pharmacal Co. Schuylkill Chemical Co. R. Schattner Co. William H. Rorer Syntex Fox Pharmacal, Inc. Smith, Kline, & French Stiefel labs Campana Corporation E.R. Squibb and Sons

Fostril Pernox Fostex Cake Fostex Cream Transact Bio-Clear Medicated Cream Persadox Cream Persadox Lotion Alcloxa, Allantoin Chloraderm Loroxide Lotion Vanoxide Lotion Microsyn Acne Lotion Aktex Acnomel Acne Cake Acnomel Acne Cream Sulfoxyl Cream Strong Sulfoxyl Lotion Strong Cuticura Acne Cream (Cutitone) Epi*Clear Acne Lotion, Epi*Clear Acne Scrub Cleanser, Epi*Clear Acne Soap, Epi*Clear Squibb Acne Kit Listerex Antibacterial Scrub Persol Mudd Acne-Dome Medicated Cleanser Acne-Dome Cream, Lotion Stri-dex Medicated Pads Listerex Herbal Scrub Bare Face Acne Skin Medicine Oxy-10, Oxy-5 Komex Acne Scrub bp Gel Medication Strong, bp Gel Medication Komex Acne Scrub Hospital Brand Acne Cream Clearasil Stick Clearasil Regular Tinted Clearasil Vanishing Cream Oxy-5 Oxy-10

070155-56 070168 070172 070173-5 070181 070188 070191 070199 070206 070207 070218 070230 070234-6 070238

Warner-Lambert Carter Products Chattem Labs Dome (division of Miles) Sterling Drug, Inc. Warner-Lambert Pennwalt Corp. Norcliff Thayer Barnes-Hind Pharmaceuticals AHC Pharmacal Barnes-Hind Pharmaceuticals H.B. Distributing Co. Vick Divisions Research Norcliff Thayer

070239 070242 070243 070244 070245 070247 070248 070249 070250 070255 070256 070259 070260 070261 070262 070263 070264 070268 070269 070270 070271 070272 020273 070274 070275 070276 070277 070278 070279 070280 070281

Purdue Frederick Co. Sterling Drug, Inc. Purdue Frederick Co. Bowman Pharmaceuticals, Inc. Press Chemical & Pharmaceuticals labs, Inc. Sterling Drug, Inc. dome (division of Miles Lab, Inc.) Sterling Drug, Inc. Dome Procter & Gamble Avon Products, Inc. Stiefel Labs, Inc. Sterling Drug, Inc. Stiefel Labs, Inc. The Proprietary Assn. Herbert labs Vick Divisions Research Westwood Pharmaceuticals Vick Divisions Research Herbert Labs Vick Divisions Research Vick Divisions Research Westwood Pharmaceuticals Westwood Pharmaceuticals Warner-Lambert Co. Press Chemical Co. The Proprietary Assn. Vick Divisions Research Vick Divisions Research Vick Divisions Research Ketchum Labs. Inc.

Betadine Skin Cleanser Stri-dex Chemistry of povidone-iodine Bowman Drawing Paste Wpsal Ointment Campho-Phenique Liquid Vlem-Dome Campho-Phenique Liquid Vlem-Dome Tetracycline Clear Skin Medicated Blemish Cream Sulfoxyl Lotion Salicylic acid SAStid Soap Benzoyl peroxide safety Benzoyl peroxide Benzoyl peroxide Pernox Resorcinol Benzoyl peroxide Resorcinol Clearasil Laureth-4 (Polyoxyethylene-lauryl ether) Polyethylene Granules Thymol and polyethylene Epsal Ointment Proposed Labeling Resorcinol Antibacterial activity and protocol for in vivo testing Prevention of new acne lesions Propa pH Super Cleaner

070282 070283 070284 070285 070286 070287-8 070289 070290 070291 070292 070293 070294 070295-296 070297-300 07BPA1 07BPA2A&B 07BPA3 07BPA4

Sterling Drug Inc. Upjohn Co. Vicks Divisions Research Vick Divisions Research Sterling Drug Inc. Koppers Co. Stiefel Labs, Inc. Vick Divisions Research Dermik Labs

Stri-dex Plexion Resorcinol In vitro protocol Salicylic Acid Resorcinol Benzoyl peroxide and sulfur Resorcinol Vlemasque Presentation and submissions to Panel November 14-15, 1980 Benzoyl peroxide antimicrobial activity Benzoyl peroxide Acne References, Uncited Acne References, Cited Panel’s Administrator’s File, Volume I - General Panel’s Administrator’s File, Volume II - Minutes of Panel meetings Panel Administrator’s File, Volume III - Correspondence File (1977 1979) Panel Administrator’s File, Volume IV - Correspondence File (1980 1981)

The Proprietary Assoc. Information, Inc.

TFM VOLUME

07BTFM

Has been established for Topical Acne Drug Products

Topical Antifungal Drug Products for OTC Human Use Establishment of a Monograph and Reopening of Administrative Record Docket No. 80N-0476 Volume 07APA5 In the FEDERAL REGISTER of September 7, 1982 (47 FR 39464), the administrative record for the OTC topical antifungal drug products rulemaking was reopened to include a statement on OTC Drug Products for the Treatment of Diaper Rash by the Advisory Review Panel on OTC Miscellaneous External Drug Products. To avoid duplication, the Public Administrative File for that statement appears as part of the administrative file for the OTC external analgesic drug products rulemaking (Docket No. 78N-0301) that was also reopened on September 7, 1982 (47 FR 39412). The material included in the topical anitfungal rulemaking is identified in OTC Volume 06BPA6 in the external analgesic administrative file.

Public Administrative File OTC Oral Mucosal Injury Drug Products (Docket No. 78N-0196)

080015 080016 080043 080050 080063 080071 080072 080094 080132 080134B 080140 080144 080145 080147 080156 080168

International Pharmaceutical Corp. Rystan Co., Inc. Carter Products A-Trol Laboratories McKesson Laboratories McKesson Laboratories International Pharmaceutical Corp. Carter Products International Pharmaceutical Corp. Cooper Laboratories, Inc. Warner-Lambert Church & Dwight Co., Inc. Carter Products Rystan Co., Inc.

Gly-Oxide Liquid Chloresium Toothpaste, Dental Ointment, Solution Hydrogen Peroxide I.D. Denture Medication Ora-Fix Documented Case Reports Gly-Oxide Liquid Additional Data Aerodent Green IV Dentifride Gly-Oxide Liquid Additional Data Amosan Listerine Sodium Bicarbonate Green IV Additional Data Chloresium Toothpaste, Dental Ointment, and Solution Additonal Data

080175 080181 080184 080189 080190 080219 080220 080244 080247

Cooper Lanboratories, Inc. International Pharmaceutical Corp. International Pharmaceutical Corp. International Pharmaceutical Corp. Merrell-National Laboratories Carter Products Cooper Laboratories Inc. Church & Dwight Co., Inc. Cooper Laboratories, Inc.

Amosan Additional Data Gly-Oxide Liquid Additional Data Gly-Oxide Liquid Additional Data Gly-Oxide Liquid Additional Data Cepacol Mouthwash Green IV Additional Data Amosan Additional Data Sodium Bicarbonate Additional Data Amosan Additional Data

Public Administrative File OTC Oral Mucosal Injury Drug Products (Docket No. 78N-0196) General Dental Submissions
VOLUME 080058 080059 080061 080064 SOURCE FDA FDA FDA FDA REMARKS NAS/NRC (DESI) Reports. (Panel on Drugs Used in Dentistry) Cross Index to Data Submission. 35th and 36th Editions of “Accepted Dental Therapeutics” Furnished at Panel’s Request. OTC Drug Literature Program XI. Dental Products A. Benzocaine B. Camphor C. Choline Salicylate D. Erythrosin E. Eugenol F. Hydrogen Peroxide G. Karaya Gum, Powdered H. Potassium Iodide J. Silver Nitrate K. Tannic Acid OTC Drug Literature Program X. Dentifrices-Part I (A-F) A. Reviews B. Ammoniated Dentifrices C. Ammonium Phosphate, Dibasic D. Chloroform E. Dicalcium F. Fluoride, General OTC Drug Literature Program X. Dentifrices-Part II (G-K) G. Formaldehyde H. Hydrogen Fluoride J. Sodium Borate K. Sodium Fluoride OTC Drug Literature Program X. Dentifrices Part-III (L-O) L. Sodium Monofluorophosphate M. Sodium N-Lauroyl Sarcosinate N. Stannous Fluoride O. Strontium Chloride Color Additive Regulations-1974 (Requested by Panel). Labels from All Submissions.

080065

FDA

080066

FDA

080067

FDA

080106 080236

FDA FDA

Public Administrative File OTC Oral Mucosal Injury Drug Products (Docket No. 78N-0196) Alphabetical Listing of References Cited in Report
VOLUME 080262 080263 CONTENTS A-H I-R

080264 080265

S-Z Miscellaneous Uncited References

Public Administrative File OTC Oral Mucosal Injury Drug Products (Docket No. 78N-0196) Panel Administrator’s File
VOLUME CONTENTS

080PA1

Panel Administrator’s File (Correspondence File), Volume 1 Contents 1.0 Table of Contents 1.1 Calls for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae for Panel Members 1.4 General and Specific Charges 1.5 List of Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exemption and Environmental Assessment Report Panel Administrator’a File (Correspondence File), Volume II, Meeting Summary Minutes. Panel Administrator’s File (Correspondence File), Volume III (1973-1978).

080PA2 080PA3

Public Administrator’s File OTC Anticaries Drug Products Docket No. 80N-0042
VOLUME 080007 080008 080011 SUBMITTED BY Whitehall Labs, Inc. The Lorvic Corp. The Lorvic Corp. TRADE NAME/SUBJECT Super-white Kolynos Toothpaste Coral II Phosphate, Fluoride Prophylaxis Paste Karidium Phosphate Fluoride Topical Gel

080012 080018 080019 080022 080023 080030 080031 080040 080041 080043 080049 080052 080053 080056 080057 080058A 080060 080062 080083 080092 080097 080098 080099 08 0102 080103 080109 080115 080118 080119 080123

The Lorvic Corp. Lever Brothers Proctor & Gamble Co. Proctor & Gamble Co. Sterling Drug Co. Sterling Drug Co. Beecham Products Rystan Co., Inc. The Lorvic Corp. Carter Products Carter Products Dr. Lester D. Apperson (CTFA Liaison Rep.) Lorvic Corp. FDA American Pharmaceutical Association NDK Company Barnangan AB Dr. Lester D. Apperson (CTFA Liaison Rep.) Proctor & Gamble Co. Proctor & Gamble Co. Proctor & Gamble Co. Janar Co., Inc. Dr. Lester D. Apperson (CTFA Liaison Rep.) Warner lambert FDA Proctor & Gamble Co. Colgate-Palmolive Beecham Products

Karidium Phosphate Fluoride Topical Solution Aim Stannous Fluoride Toothpaste Gleen II Toothpaste Crest Toothpaste Caroid Tooth Powder Phillips Toothpaste McLeans Toothpaste Chloresium Toothpaste Dental Ointment Solution Karidium Phospate Fluoride Topical Gel and Solution Additional Data Sodium Fluoride Polymethylmethacrylate Dicalcium Phosphate Dentifrices Stannous Fluoride Status of Topical Fluoride Preparations Fluoride Dentifrices NDK Dentifrice Vademecum Chewing Gum Sodium Fluoride Anticaries Agents Crest Toothpaste Gleem II Toothpaste Iradicav Sodium Monofluoro-phosphate Dentifrices Sodium Fluoride Rinse Additional Data Workshop on Fluorides and Dental Caries Reduction Stannous Fluoride Dentifrices Sodium Monofluoro-phosphate Dentifrices Additional Data McLeans Toothpaste Additional Data

080126 080127 080128 080131 080133 080134 080134A 080135 080136 080137 080138 080139 080141 080141A 080142 080143 080143B 080146 080148 080149 080150 080152 080153 080154 080155 080155A 080159 080160 080168 080173 080174

Beecham Products Lever Brothers Colgate-Palmolive Church & Dwight Beecham Products Colgate-Palmolive

McLeans Toothpaste Additional Data Aim Stannous Fluoride Toothpaste Fluoride Dentifrice Arm & Hammer Baking Soda, Arm & Hammer Toothpaste McLeans Toothpaste Additional Data Sodium Fluoride Sodium Bicarbonate Dentifrice Additional Data Acidulated Fluoride-Phosphate Mouth Rinse McLeans Toothpaste Additional Data Sodium Monofluoro-phosphate Crest Toothpaste DiCal Chewing Gum DiCal Chewing Gum Fluoride Dentifrices Testing DiCal Chewing Gum DiCal Chewing Gum Perident Salt Toothpaste Iradicav Additional Data Stannous Fluoride Mouthrine Tablet Agents Used to Formulate Dentifrices Silica Based Dentifrice Containing NaMFP Additional Data MFP Dentifrices Additional Data Fluoride Dentifrices

Warner lambert Beecham Products Colgate-Palmolive Proctor & Gamble Co. Warner lambert Warner lambert Lever Brothers Warner Lambert Warner Lambert Perident Co., Inc. Janar Co., Inc. Warner Lambert CTFA - PA Dentifrice Task Force Lever Brothers Colgate-Palmolive CTFA - PA Dentifrice Task Force Beecham Products Warner Lambert Rystan Co., Inc. CTFA - PA Dentifrice Task Force Colgate-Palmolive

Fluoride Dentifrice Additional Data DiCal Chewing Gum Chloresium Toothpaste Dental Ointment and Solution Additional Data Laboratory Profile on Fluoride Dentifrices Colgate Dental Cream

080176 080177 080178 080179 080182 080185 080192 080194 080195

Beecham Products Lever Brothers Proctor & Gamble Co. Warner Lambert Lever Brothers Colgate-Palmolive Colgate-Palmolive Colgate-Palmolive Carter Products

Fluoride Dentifrices Laboratory Profile on Fluorides Laboratory Profile on Fluorides DiCal Chewing Gum Aim Stannous Fluoride Toothpaste Additional Silica/MFP Dentifrices Abrasive/MFP Combination Sodium Bicarbonate/ Sodium Fluoride Fluoride in Polymethylmethacrylate-Based Dentifrice Additional Data Fluoride Mouthrinses Vademecum Sugarless Gum Additional Data Aim Stannous Fluoride Tooth paste Additional Data Dentifrice Definitions Pearl Drops Dentifrice Aim Stannous Fluoride Toothpaste Additional Data Dentifrice Definitions Dentifrice Definitions Dentifrice Definitions Stannous Fluoride Silica Gel Fluoride Dentifrices Fluoride Dentifrices Additional Data MFP Silica Based Dentifrice Additional Data Aim Stannous Fluoride Toothpaste Additional Data Fluoride Dentifrice Testing Sodium Monofluoro-phosphate Dentifrices Laboratory Profiles on Fluorides

080197 080199 080200 080201 080202 080204 080205 080206 080207 080209 080210 080215 080217 080232 080233 080235 080237

Warner Lambert Barnagen AB Lever Brothers Colgate-Palmolive Carter Products Lever Brothers Carter Products Proctor & Gamble Co. Beecham Products Lever Brothers Lever Brothers Colgate-Palmolive Lever Brothers Lever Brothers Lever Brothers Colgate-Palmolive Proctor & Gamble/PA task force

080238 080243 080245 080246 080248 080249 080251 080253 080256 080260

Lever Brothers Proctor & Gamble Co. The Proprietary Association Church & Dwight The Proprietary Association Proctor & Gamble Co. Lever Brothers The Proprietary Association Westwood Research Life Savers, Inc. & CSR, Limited

Laboratory Profiles on Fluorides Laboratory Profiles on Fluorides Laboratory Profiles on Fluorides Sodium Bicarbonate Standards for Fluoride Dentifrices Crest Toothpaste Gleem Toothpaste Proctor & Gamble Co. Submission 080249 Reference Formulations Testing Procedures for Fluoride Dentifrices Calcium Sucrose Phospate

Public Administrative File OTC Anticaries Drug Products (Docket No. 80N-0042) General Dental Submissions
VOLUME 080058 080059 080061 SOURCE FDA FDA FDA REMARKS NAS/NRC (DESI) Reports. (Panel on Drugs Used in Dentistry) Cross Index to Data Submission. 35th and 36th Editions of “Accepted Dental Therapeutics”-Furnished at Panel’s Request.

080064

FDA

080065

FDA

080066

FDA

080067

FDA

080106 080236

FDA FDA

OTC Drug Literature Program XI. Dental Products A. Benzocaine B. Camphor C. Choline Salicylate D. Erythrosin E. Eugenol F. Hydrogen Peroxide G. Karaya Gum, Powdered H. Potassium Iodide J. Silver Nitrate K. Tannic Acid OTC Drug Literature Program X. Dentifrices-Part I (A-F) A. Reviews B. Ammoniated Dentifrices C. Ammonium Phosphate, Dibasic D. Chloroform E. Dicalcium Phosphate F. Fluoride, General OTC Drug Literature Program X. Dentifrices-Part II (G-K) G. Formaldehyde H. Hydrogen Fluoride J. Sodium Borate K. Sodium Fluoride OTC Drug Literature Program X. Dentifrices-Part III (L-O) L. Sodium N-Lauroyl M. Sodium N-Lauroyl Sarcosinate N. Stannous Fluoride O. Strontium Chloride Color Additive Regulations-1974 (Requested by Panel). Labels from All Submissions.

Public Administrative File OTC Anticaries Drug Products (Docket No. 80N-0042) Alphabetical Listing of References Cited in Report
VOLUME 080266 080267 080268 080269 080270 CONTENTS A-F G-H I-M N-Z Miscellaneous Uncited References

Public Administrative File OTC Anticaries Drug Products (Docket No. 80N-0042) Panel Administrator’s File
VOLUME 08APA1 CONTENTS Panel Administraotr’s File, Volume I - General 1.1 Calls for Data 1.2 List of Panel Memebrs and Liaisons 1.3 Curriculum Vitae for Panel Members and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index of Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exemption and Environmental Assessment Reprot Panel Administrator’s File, Volume II - Minutes of Panel Meetings Panel Administrator’s File, Volume III - Correspondence File, (1972-1974). Panel administrator’s File, Volume IV - Correspondence File, (1975-1976).

08APA2 08APA3 08APA4

08APA5

Panel Administrator’s File, Volume V - Correspondence File, (1977-1979)..

Public Administrative File OTC Drug Products For the Relief of Oral Discomfort (Docket No. 80N-0228)
VOLUME 080001 080002 080003 SUBMITTED BY Abbott Laboratories Eneglotaria Medicine Co., Inc. Of Puerto Rico C.S. Dent & Co. TRADE NAME/SUBJECT Butyn Metaphen Dental Ointment Gotas Dentil, Erpen Dent’s Toothache Drops Treatment, Dent’s Toothache Gum, Dent’s Lotion-Jel, Dent’s Dental Poultice Desensitizer Pain-A-Lay Dent-Zelite Benzodent Cheramist # 30 Kank-A Sensodyne Dr. Hand’s Teething Lotion, Dr. Hand’s Teething Gel Chloraseptic Mouthwash and Gargle, Chloraseptic Lozenges, Chloraseptic Aerosol Spray Thermodent Ora-Jel, Baby Ora-Jel, Ora-Jel D

080010 080013 080014 080017 080028 080032 080033 080034 080035 080036 080037 080042 080048

The Lorvic Corp. Denver Chemical Manufacturing Co. Zelite Corp. Vick Chemical Co. K.I.K. Co. John Arthur Geyer Co. Block Drug Co. Inc. Denver Chemical Manufacturing Co. Norwich Pharmacal Co.

Pfizer, Inc. Commerce Drug Co., Inc.

080052 080054 080055 080057 080060 080063 080064 080070 080071 080072 080073 080081 080084 080085 080086 080089 080093 080095 080101 080107 080112 080114 080117 080118 080119 080125 080128 080152

Carter-Wallace, Inc. Sterling Drug, Inc. Whitehall Laboratories, Inc. Dr. Robert Stearns (Lorvic Corp.) AphA A-trol Laboratories FDA Zelite Corp. McKessan Laboratories Zelite Corp. Block Drug Co., Inc. Eaton Labs. Div. Of Morton-Norwich Products, Inc. International Pharmaceutical Corp. American Dental Association Sterling Drug, Inc. Sterling Drug, Inc. International Pharmaceutical Corp. Whitehall Laboratories, Inc. International Pharmaceutical Corp. Warner Lambert Co. Commerce Drug Co. International Pharmaceutical Corp. Colgate-Palmolive Co. Colgate-Palmolive Co. Whitehall Laboratories, Inc. Colgate-Palmolive Co. CTFA-PA Dentifrice Task Force

Sodium Fluoride General Safety and Efficacy Data Campho-Phenique Anbesol Article on Stannous Fluoride Letter of 5-21-73 Regarding Fluoride Dentifrices I.D. Denture Medication FDA Literature Search Dental Products Abstracts Dent-Zelite Additional Data Ora-Fix-M Dent-Zelite Additional Data Jiffy Toothache Drops Chloraseptic Mouthwash and Gargle Additional Data DeSense Dental Gel Data on Toothache Preparations Campho-Phenique Additional Data Campho-Phenique Additional Data on Rationale for Inclusion of Camphor Protect Dental Gel Anbesol Additional Data Protect Dental Gel Additional Data Thymol Additional Data Ora-Jel Additional Data Protect Dental Gel Additional Data and Protocol for a Clinical Study Additional Data (Stability) Additional Data on Sodium Monoflurophosphate Anbesol Additional Formulation Data Suggested Guidelines for Fluoride Dentifrices Agents Used to Formulate Dentifrices

080173 080174 080176 080177 080178 080180 080191 080193 080198 080210 080211 080212 080213 080214 080216 080221 080222 080223 080224 080225

CTFA-PA Joint Task Force Colgate-Palmolive Co. Beecham Products, Inc. Lever Brothers Procter and Gamble Co. The Rilox Coo. Block Drug Co., Inc. Whitehall Laboratories, Inc. Block Drug Co., Inc. Lever Brothers Abbott Laboratories Block Drug Co., Inc. Glenbrook Labs., Div. Of Sterling Drug, Inc. Marion laboratories, Inc. Proprietary Association Block Drug Co., Inc. Marion Laboratories, Inc.

Summary of Laboratory Profile on Fluoride Dentifrices Sodium Monofluorophosphate Summary of Laboratory Profile Data on Fluoride Dentifrice Expiration Dating Data on Fluoride Laboratory Testing Profile and Expiration Dating Data on Laboratory Testing Profile for Fluoride Creole Toothpaste Wax Poloris Dental Poultice Comments on Proposed Ethanol Limits Sensodyne Additional Data Formulation Changes for Fluoride Dentifrices Butyn Dental Ointment Additional Studies Poloris Dental Poulice Additional Data Campho-Phenique Additional Data Protect Dental Gel Additional Data Protocol Guidelines for Densensitizing Dentifrices Sensodyne Additional Efficacy Data Protect Dental Gel Additional Safety Data on Pluronic Polyolis in General, Pluronic F-127 and Efficacy Data Comparative Active and Placebo Formulation Data Toxicity Data on Pluronic Polyols Potassium Nitrate Toothpaste Potassium Nitrate Toothpaste Testing Methodology Potassium Nitrate Toothpaste Testing Methodology Proposed Protocol Fluoride Profiles Fluoride Laboratory Profile Tests Protocol for Testing Tooth Desensitizers Presentation on Tooth Desensitizer Testing

080226 080227 080229 080230 080231 080237 080238 080239 080240

Block Drug Co., Inc. BASF Wyandotte Corp. Vick Chemical Co. Vick Chemical Co. Vick Chemical Co. Proctor and gamble Co./PA Task Force Lever Brothers Proprietary Association Proprietary Association

080241 080243 080245 080248 080250 080250A 080252 080253 080254 080255 080256 080257 080258 080259

Vick Chemical Co. H.V. Shuster & Co. PA Task Force PA Task Force Sanlor Laboratories Sanlor Laboratories Marion Laboratories, Inc. PA Subgroup on Fluoride Dentifrices Sanlor Laboratories Commerce Drug Co., Inc. Westwood Research Lab Block Drug Co., Inc. Whitehall Laboratories, Inc. Vick Chemical Co.

Status of Potassium Nitrate as a Tooth Desensitizer Stannous Fluoride/IMP Laboratory Profile Fluorides Laboratory Profile Standards for Fluoride Dentifrices Endoflas, F.S. Endoflas, F.S. Appendix Protect Dental Gel Additional Data Fluoride Dentifrices Reference Formulations Endoflas, F.S. Additional Data Baby Ora-Jel Additional Data Testing Procedures on Fluoride Dentifrices Sensodyne New Clinical Study Anbesol Additional Data Testing Method for Tooth Desensitizers Additional Data

Public Administrative File OTC Drug Products for the Relief of Oral Discomfort (Docket No. 80N-0228) Genreal Dental Submissions
VOLUME 080058 080059 080061 080064 SOURCE FDA FDA FDA FDA REMARKS NAS/NRC (DESI) Reports. (Panel on Drugs Used in Dentistry) Cross Index to Data Submission. 35th and 36th Editions of “Accepted Dental Therapeutics”-Furnished at Panel’s Request. OTC Drug Literature Program XI. Dental Products A. Benzocaine B. Camphor C. Choline Salicylate D. Erythrosin E. Eugenol F. Hydrogen Peroxide G. Karaya Gum, Powdered H. Potassium Iodide J. Silver Nitrate K. Tannic Acid OTC Drug Literature Program X. Dentifrices-Part I (A-F) A. Reviews B. Ammoniated Dentifrices’ C. Ammonium Phosphate, Dibasic D. Chloroform E. Dicalcium Phosphate F. Fluoride, General OTC Drug Literature Program X. Dentifrices-Part II (G-K) G. Formaldehyde H. Hydrogen Fluoride J. Sodium Borate K. Sodium Fluoride

080065

FDA

080066

FDA

080067

FDA

OTC Drug Literature Program X. Dentifrices-Part III (L-O) L. Sodium Monofluorophosphate M. Sodium N-Lauroyl Sarcosinate N. Stannous Fluoride O. Strontium Chloride Color Additive Regulations-1974 (Requested by Panel). Labels from All Submissions.

080106 080236

FDA FDA

Public Administrative File OTC Drug Products for the relief of Oral Discomfort (Docket No. 80N-0228) Alphabetical Listing of References Cited in Report

VOLUME 080271 080272 080273 080274

CONTENTS A-F G-P Q-Z Miscellaneous Uncited Reference

Public Administrative File OTC Drug Products for the Relief of Oral Discomfort (Docket No. 80N-0228) Panel Administrator’s File
VOLUME CONTENTS

08BPA1

Panel Administrator’s File, Volume I - General

08BPA2

1.1 Calls for Data 1.2 List of Panel Memebrs and Liaisons 1.3 Curriculum Vitae for Panel Members and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index of Panel Submissions 1.6 Minutes of Panel Meetings Panel Administrator’s File Volume II - Correspondence File, (1972-1982).

LAXATIVE, ANTIDIARRRHEAL, EMETIC, ANTIEMETIC OVER THE COUNTER DRUGS, DATA SUBMITTED FOR REVIEW

VOLUME 090001 090002

SUBMITTED BY Lewis-Howe Company Combe Inc.

TRADE NAME Concentrated Milk of Magnesia Espotabs

INGREDIENTS LISTED Milk of Magnesia Yellow Phenolphthalein

CLAIMS As a Laxative As a laxative

090003

Lewis-Howe Co.

090004

Riker labs.

Nature’s Remedy Regular; Nature Remedy Candy Coated; Nature’s Remedy Juniors Dorbane Dorbantyl Dorbantyl Forte

Aloe, Cascara Sagrada

A dependable, all vegetable, family laxative for the relief of occasional constipation Promotes colonic peristalsis and is a superior laxative in the management and treatment of constipation. As antacid-Astrigent for simple diarrhea and temporary relief of gastric discomfort due to overeating or other dietary indiscretions. For treating constipation due to hardness or lack of moisture in the intestinal contents, an effective fecal softener whose action will help to restore normal bowel function gradually, without griping or acute discomfort.

Danthron

090005

Merrick Medicine Company

Percy Medicine

Bismuth Subnitrate Rhubarb Fluidextract Potassium Carbonate Calcium Hydroxide Dioctyl Sodium Sulfosuccinate Sodium Carboxymethylcellulose Casanthranol

090006

ICI America Inc.

Dialose Dialose Plus Effersyllium Instant Mix

090007 090008

Burton, Persons & Company Burton, Parsons & Company Burton, Parsons & Company

L.A. Formula Psyllium Hydrophilic Mucilloid with Dextrose Konsyl

090009

Psyllium Hydrophilic Mucilloid Psyllium Hydrophilic Mucilloid with Dextrose Psyllium Hydrophilic Mucilloid

Provides a bland non-irritation bulk and lubricating effect to promote normal elimination.

090010

C.B. Fleet Company, Inc.

Fleet Enema Fleet Enema Pediatric

090011

C.B. Fleet Company, Inc.

Fleet Buffered Laxative Fleet Buffered Laxative, Flavored

Sodium Biphosphate Sodium Phosphate Monosodium Phosphate Disodium Phosphate Sodium Gentle regulated and Biphosphate predictable Monosodium elimination. Phosphate Sodium Phosphate Disodium Phosphate

090012

National Magnesia Co., Inc.

National Solution of Citrate of Magnesia

090013

Wyeth Laboratories, Inc.

Petrogalar Plain

Anhydrous Tribasic Alkalizing laxative. Magnesium Citrate, Anhydrous Citric Acid, Anhydrous Tribasic Sodium Citrate Aqueous Suspension Laxative of Mineral Oil Phenolphthalein in Aqueous Suspension Mineral Oil Cascara Sagrada in an Aqueous Suspension of Mineral Oil Glycerine Suppositories Glycerine Suppositories

Phenolphthalein Petrogalar

Cascara Petrogalar

Laxative

Glycerine Suppositories Adult Glycerine Suppositories Children 090014 Wyeth Laboratories, Inc. Kaomagma Kalpac Polymagma plain Polymagma Plain Tablets

090015

U.S.V. Pharmaceutical Corporation U.S.V. Pharmaceutical Corporation Dorsey Laboratories

Neo-Cultol

Kaolin in Alumina Gel Kaolin in Alumina Gel with Pectin Activated Attapulgite, Pectin Activated Attapulgite, Pectin Hydrated Alumina Powder Mineral Oil Jelly

Use of Glycerin Suppositories will be found more convenient than enemas and more rapid in action than purgatives given by mouth. For the control of Diarrhea an activated fluid adscrbent

Control of diarrhea For intestinal lubrication as a gentle corrective in constipation. Relief of diarrhea and associated renal discomfort. For bowel evacuation of the lower bowel in most common types of constipation. Vacuetts are nonirritating to rectal mucosa and nonhabit forming.

090016

Bacid

090017

Vacuetts Suppositories

Lactobacillus Acidophilus Sodium Carboxymethyl Cellulose Sodium Biphosphate Anhydrous Sodium Acid Pyrophosphate Sodium Bicarbonate

090018

Abbott Laboratories

Maltsupex Filmtab Maltsupex

Malt Soup Extract Malt Soup Extract Solids

090019

Abbott Laboratories

Syllamalt Powder

Malt Soup Extract Blond Psyllium Seed Husks

090020

Abbott Laboratories

Syllamalt Effervescent Sigmol Enema Modane Modane, Mild Acidophilus Concentrate Rectalad Enema

090021 090022-090023 090024 090025

Pharmaseal Laboratories, Inc. Warren-Teed Pharmaceuticals Inc. Lacto Products Company Denver chemical Mfg., Co. Whitehall Laboratories Inc. Warner-Lambert Company

Malt Soup Extract Powder Blond Psyllium Seed Husks Sorbitol USP Dioctyl Potassium Sulfosuccinate Dathron d-Calcium Pantothenate Lactobacillus Acidophilus Glycerin Diotyl Potassium Sulfosuccinate Dioctyl Sodium Sulfosuccinate Bile Salts Phenolphthalein Ext. Cascara Sagrada Oleoresin Capsicum Bile Salts Phenolphthalein Ext. Cascara Sagrada Oleoresin Capsicum Senna Senna Senna Senna Plantago Ovata Husk Methyl Cellulose

A natural corrective for chronic constipation, laxative dependence and rectal itching. Effective, non-habit forming, it promotes soft, easily passed stools. Natural barley extract and psyllium seed husks are combined to promote bowel regulatory. Effective, non-habit forming. Promotes bowel regularity. Soften stools and serves to provide bulk. Sodium-Free Non-irritating. Laxative Used to change the bacterial flow of the intestinal tract. To relieve occassional or temporary constipation. Softens dry hard stools for easier, more comfortable passage. Temporary relief of constipation.

090026

Preparation H (NonLaxative Regulator) Veracolate

090027

090028

Warner-Lambert Company

Veracolate

Temporary relief of constipation.

090029

Chattem Drug and Chemical Company

090030 Vol. I

J.B. Williams Co., Inc.

Black-Draught Granulated Black-Draught Senna-Lax Tablet Black-Draught Powder Black-Draught Syrup of Serutan Concentrated Powder

Laxative Laxative Laxative Laxative Aid to regularity

090031 Vol. II 090032 090033 Vol. I 090034 Vol. II 090035

J.B. Williams Co., Inc. J.B. Williams Co., Inc. Ex-Lax, Inc.

Serutan Concentrated Fruit Flavored Serutan Toasted Granules Ex-Lax Chocolated Ex-Lax Unflavored Ex-Lax Instant Mix

The Upjohn Company

Imbicoll with Cascara Imbicoll with Vitamin B1

Plantago Ovata Husk Methyl Cellulose Plantago Ovata Husk Methyl Cellulose Yellow Phenolphtalein Yellow Phenolphtalein Yellow Phenolphtalein Vegetable Gum, Cascara Sagrada Vegetable Gum, Thiamine Hydrochloride Phenolphthalein Kaolin, Pectin Kaolin, Pectin Tincture of Opium, Homatropine Methlbromide, Pectin Psyllium Hydrophyllic Mucilloid Dimenhydrinate Dimenhydrinate Danthron, Dioctyl Sodium Sulfosuccinate Danthron, Dioctyl Calcium Sulfosuccinate Dioctyl Sodium Sulfosuccinate Dioctyl Sodium Sulfosuccinate Dioctyl Calcium Sulfosuccinate Sodium Bicarbonate, Sodium Carbonate, Tartaric Acid

Aid to regularity Aid to regularity Relief of Constipation. Laxative.

Laxative Bulkproducing aid.

090036 090037 090038

The Upjohn Company The Upjohn Company International Pharmaceutical Corporation

Phenolax Wafers Kaopectate Kao-Con Dia-Quel Liquid

090039

Searle Laboratories

Metamucil powder Metamucil instant Mix Dramamine Dramamine Liquid Doxan

090040 Vol. I 090041 Vol. II 090042 Vol. I &

Searle Laboratories Searle Laboratories Hoechst Pharmaceuticals, Inc.

Doxidan

Relief of constipation. Treatment of diarrhea. Rapid control of diarrhea, relief of cramping, colickky pain and nausea, soothes and protects intestinal tract. Treatment of constipation, promotes natural elimination. Prevent travel sickness. Prevent travel sickness. Laxative with stool softener an aid in the treatment of temporary constipation.

090043 Vol. II

Doxinate Doxinate Solution Surfak

090044

Beecham, Inc.

ENO

Mild Laxative.

090045 Vol. I &

A.H. Robins Company

Donnagel

Kaolin, Pectin, Hyoscyamine Sulfate, Atropine Sulfate, Hyoscine Hydrobromide Kaolin, Pectin, Hyoscyamine Sulfate, Atropine Sulfate, Hyosine Hydrobromide, Powdered Opium, USP Dioctyl Sodium Sulfosuccinate Yellow Phenolphthallein Frangula, Sterculia Yellow Phenolphthalein Levulose, Dextrose, Ortho-phosphoric Acid For nausea and vomiting. Relief of upset stomach and nausea associated with Colds, Food indiscetions, emotional upsets and travel discomfort. Upset stomach, indigestion, nausea and controls diarrhea. Relief for upset stomach, ingestion, nausea, common diarrhea. Mild Laxative.

090046 Vol. II

Donnagel

090047

Plough, Inc.

Correctol

Women’s gentle laxative. All vetable laxative for planned regularity.

090048 090049 Vol. I 090050 Vol. II 090051

Plough, Inc. Plough, Inc.

Saraka Feen-A-Mint Gum and Mints Emetrol

William H. Rorer, Inc.

090052 Vol. I & 090053 Vol. II 090054 Vol. I 090055 Vol. II 090056 Vol. III

Norwich Pharmacal Company

Pepto-Bismol

Norwich Pharmacal Company

Pepto-Bismol Chewable Tablets

Bismuth Subsalicylate Salol NF Zinc Phenolsulfonate Bismuth Subsalicylate Precipitated Calcium Carbonate, USP Glycocoll

090057

Whitehall Laboratories, Inc.

Petro-Syllium plain

Psyllium Seed, NF Mineral Oil, Protol, USP

Relief for constipation, softens hard stool and helps to move it through the intestinal tract comfortably. Relief of constipation, nonfattening liquid emulsion of mineral oil. Passes through stomach and upper intestine without upset or dyhydrationg effect. Laxative. Laxative, temporary relief of constipation. Relief of constipation. Promotes normal bowel movement, assures soft stool. Same as Kondremul with Cascara. Temporary relief of constipation, when severe symtoms of constipation have subsided, satisfactory action will usually be obtained by changing to Kondremul plain. Special formula to afford intestinal bulk and lubrication. Gentle laxative antacid lubricant. Same as Haley’s MO but in Spanish Laxative

Petro-Syllium with Phenolphthalein

Plantago Seed, NF Mineral Oil, USP Phenolphthalein

090058 090059

Sandoz Pharmaceuticals Cooper Laboratories, Inc.

Glysennid Tablets Kondremul Plain

Sennosides A and B Mineral Oil, USP

Kondremul with Cascara

Mineral Oil, USP Cascara Ext.

Kondremul with Phenolphthalein Neo-Kondremul

Mineral Oil, USP Phenolphthalein Mineral Oil, USP Casathranol

090060 090061

Sterling Drug Inc. Sterling Drug Inc.

Mucilose Flakes Mucilose Granules Mucilose Powder Haley’s M-O

Hemicellulose of Psillium Milk of Magnesia, USP Mineral Oil Milk of Magnesia, USP Mineral Oil Tartaric Acid Sodium Bicarbonate Magnesium Sulfate Dihydrate

Mil-Par 090062 Sterling Drug, Inc. Sal Andrews Andrews Salts

090063

Sterling Drug, Inc.

Phillip’s Milk of Magnesia Phillip’s Milk of Magnesia Tablets

Milk of Magnesia Magnesium Hydroxide

Laxative Gives more complete relief than single-purpose laxatives. Is an effective antacid as well as laxative. Leading laxative specially formulated for babies and growing children. When Constipation occurs, caroid and bile salts help to restore a normal pattern of elimination. They have been found so safe and gentle that doctors have recommended their use for the relief of constipation associated with pregnancy and in heart patients where straining at the stool may cause a dangerous rise in blood pressure. Prevent nausea and vomiting of travel sickness.

090064

Sterling Drug, Inc.

Fletcher’s Castoria

Extract Senna

090065

Sterling Drug, Inc.

Caroid and Bile Salts

Extract Cascara Sagrada Phenolphthalein Desiccated Whole Bile Caroid Capsicum

090066

Pfizer Pharmaceuticals

Bonine

Meclizine Hydrochloride

090067

Parke, Davis & Company

Alophen Pills

Aloin, Extract Belladona, Powdered Ipecac Phenolphthalein Cascara Sagrada, USP Ground Cascara Sagrada, USP Ground Cascara Sagrada, USP Desiccated Whole Fresh Bile Diotyl Sodium Sulfosuccinate Diotyl Sodium Sulfosuccinate, Casanthranol Vit. A Acetate, Vit. C, Thiamine Mononitrate, USP riboflavin, USP Cyanocobalamin, Choline Dihydrogen Citrate NF Niacinamide, USP Vit. E, Dioctyl Sodium Sulfosuccinate Thiamine Hydrochloride Vit. B2, Pyridoxine Hydrochloride, Cyanocobalamin Niacinamide, Iron, Pluronic F-68 Glycerin

Temporary relief of occasional constipation. Laxative.

Casacara Sagrada FluidextractAromatic Cascara Sagrada Aromatic CAS-EVAC Kapseals Desicol D-S-S Capsules D-S-S Plus

Laxative. Laxative. Laxative. Stool softener. Laxative and stool softener. Vit./Min. formula with fecal softener.

Geriplex

Geriplex FS Liquid

Geriatic Vit. Tonic with iron and a fecal softener.

Glycerin Suppositories

Laxative, afford a quick method of emptying the lower bowel. Laxative.

Milk of Magnesia

Magnesium Hydroxide

090067 (cont.)

Pargel

Kaolin, Pectin

Antidiarrheal for treatment of diarrhea. Laxative, for the relief of functional constipation.

Siblin

Psyllium Seed Husks Thiamine Hydrochloride, USP Psyllium Seed Husk, Powdered Karaya NF Pectin NF Agar, USP Thiamine Hydrochloride, USP Aloe, USP Podophyllum Resin, USP

Siblin Tablets

Laxative. A preparation for the relief of functional constipation. Reduce the following symtoms when due only to constipation: sluggishness, bloated feeling, headache, nervousness. Anti-diarrheal. Aid to bowel regularity Temporary relief of constipation

090068

Carter-Wallace, Inc.

Carters Little Pills

090069 090070

090071

William H. Rorer, Inc. received (May 8, 1973) The Upjohn Company The Upjohn Company

Parepectolin Hydrolose Syrup

Paregoric, Pectin Kaolin Methylcellulose

Bile Salts Phenolphthalein Compound Casakol Capsules Casyllium Polykol Caster Oil Glycerine Citrate of Magnesia

090072 090073 090074 090075

The Upjohn Company The Upjohn Company The Upjohn Company Scott Laboratories, Inc.

Bile Salts, Phenolphthalein, Papain, Ext. Cascara Sagrada, Ginger Poloxalkol, Casanthranol Cascara, Psyllium Husk Powder, Prune Powder Poloxalkol Caster Oil Glycerine Citrate of Magnesia

Temporary relief of occasional constipation Bulk-Producing preparation with added laxatives Temporary relief of hard stools

Used as an emollient As an active purgative

090076

Merit Remedy Company

Gall - Solve

Oxgall, Sodium Oleate Phenolphthalein

A cholagogue mild laxative to stimulate the flow of bile, recommended for constipation, headaches or biliousness due to constipation Temporary relief of occasional constipation Gentle bowel stimulation aiding laxation relieves constipation Relieves constipation Digestive Aid, Laxative. Indigestion-after meal discomfort & fullness (particularly after fatty meals) excessive belchingconstipation For routine preradiologic bowel evacuation Rectal laxative Preradiographic bowel evacuant For gentle, reliable relief of constipation A gentle laxative, for relief of simple constipation A gentle laxative with bulk for relief of simple constipation Relieves constipation, softens stool Natural vegetable laxative, relieves constipation Laxative with bulking agent for simple constipation

Merit Cathartics 090077 The Purdue Frederick Company The Purdue Frederick Company Miles Laboratories, Inc. Senokot Granules

Cascara, Aloin, Podophyllin Oleoresin, Ginger Senna Concentrate

090078 090079

Senokot Tablets Decholin

Senna Concentrate Dehydrocholic Acid

090080 090081 090082 090083 090084 090085

Gray Pharmacal Co. The Purdue Frederick Co. Gray Pharmaceutical Co. The Purdue Frederick Co. The Purdue Frederick Co. The Purdue Frederick Co. The Purdue Frederick Co. The Purdue Frederick Co. The Purdue Frederick Co. Marcen Laboratories, Inc.

X-Prep Powder Senokot Suppositories X-Prep Liquid Gentlax S Gentlax Tablet Gentlax Granules

Senna Concentrate Senna Concentrate Senna fruit extract Senna Concentrate Dioctyl sodium sulfosuccinate Senna Concentrate Guar gum Senna concentrate Guar gum Senna concentrate Dioctyl sodium sulfosuccinate Extract senna fruit Senna concentrate Psyllium Danthron Chondrus crispus Dioctyl sodium sulfosuccinate Prune concentrate dehydrated

090086 090087 090088 090089

Senokap DSS Capsules Senokot Syrup Senokot with Psyllium Powder Acelax Tablets

090090 Vol. 1

Hynson, Wesrcott & Dunning, Inc.

Lactinex Granules

Lactobacillus acidophilus Lactobacillus bulgaricus

090091 Vol. 2

Hynson, Westcott & Dunning, Inc.

Lactinex Tablets

Lactobacillus acidophilus Lactobacillus bulgaricus

090092

E.R.Squibb & Sons, Inc.

C.T. Milk of Magnesia Mint-O-Mag Milk of Magnesia Glycerine Suppositories

Magnesium hydroxide Magnesium hydroxide Magnesium hydroxide Glycerin Mineral oil Addendum to Volume 090042

Assist in restoration & maintenance of normal intestinal flora, & to help relieve the discomforts of diarrhea & fever blisters. Assist in restoration & maintenance of normal intestinal flora, & to help relieve the discomforts of diarrhea & fever blisters. Laxative, antacid Antacid, laxative Antacid, laxative Laxative Intestinal libricant

090093

090094

090095 090096 090097 090098 090099 090100 090101 090102 090103

Hoechst Pharmaceuticals Inc. Supplemental submission Vol. 1 Hoechst Pharmaceuticals, Inc. Same as above, Volume II Eneglotaria Medicine Co., Inc. Of Puerto Rico The Purdue Frederick Co. Miles Laboratories, Inc. C.B. Fleet Co., Inc. Norwich Pharmacal Co. Bristol Myers Products Bristol Myers Products Bristol Myers Products Bristol Myers Products

Mineral Oil, U.S.P. Doxan tablets

Kao Gest Parelixir Liquid Decholin Fleet Enema Pepto Bismol Bran Bran Bran Bran

Colloidal kaolin, pectin Tincture opium, pectin alcohol Addendum to Volume 090079 Addendum to Volume 090010 Addendum to Volume 090052 Bran Pharmacology reports Reprints Reprints

For the treatment of common diarrhea Nonspecific diarrhea

090104 090105 090106 090107 090108 090109 090110 090111 090112 090113 090114 090115 090116 090117 090118

Lewis Howe Company Lewis Howe Company Lewis Howe Company Lewis Howe Company American Cyanamid Co. In House report for OTC Antiemetics In House report for Bisacodyl In House report for Guar Gum E.R. Squibb & Sons, Inc. Carter Wallace, Inc. Boehringer Ingelheim Ltd. Boehringer Ingelheim Ltd. (Volume 2) Boehringer Ingelheim Ltd. (Volume 3) Forest Laboratories Bristol-Myers Co.

Nature’s Remedy Nature’s Remedy Nature’s Remedy Nature’s Remedy Dioctyl Sodium Sulfosucinate

Supplemental submission on aloe Supplemental submission on aloe Supplemental submission on aloe Supplemental submission on aloe (no trade name)

Caster Oil Carter’s Little Pills Dulcolax Tablets Dulcolax Suppositories

Supplemental labeling submission Supplement to Volume 090068 Bisacodyl

Laxative

Mel-O-Lax Sol Hepatica

090119 Volume 1 090120 090121 090122 090123 090124 090125 090126 (Vol. 1) 090127 (Vol. 2) 090128

Norwich Pharmaceutical Co. Norwich Pharmaceutical Co. The Upjohn Company Parke Davis Co. Norwich Pharmaceutical Co. Merrick Medicine Co. Upjohn Company Merrell National Laboratories Merrell national Laboratories Bristol-Myers Products

Pepto Bismol Pepto Bismol Kaolin - pectin Alophen Pills Pepto-Bismol Rhubarb Fluidextract Kaolin-pectin Cephulac Cephulac Bran tablets

Magnesium hydroxide Sodium bicarbonate Citric acid Monosodium phosphate Supplement to Volume 090052 Supplement to Volume 090052 Supplement to Volume 090037 Supplement to Vol. 090067 Supplement to Vol. 090052 Rhubarb Supplement to Vol. 090037 Lactulose syrup (galactose and lactose) lactulose syrup (galactose and lactose)

090129 090130 090131 090132 090133 090134 090135

Bristol-Myers Products Bristol-Myers Products Bristol-Myers Products Norwich Pharmacal Co. Pfizer Published references cited in Panel Report Communication from Dr. Picchioni and copy of microfilm “Reference No. 8" cited in Panel Report Pfizer Pfizer Upjohn Upjohn Hynson, Westcott & Dunning, Inc. Sterling Drug Assorted Correspondence Panel Administrator’s File

Bran tablets Bran tablets Bran tablets Pepto-Bismol Supplement to Vol. 090052 Data submission to Panel

090136 090137 090138 090139 090140 090141 090142 090143

Bovine tablets Scopolamine hydrobromide supplement to 090037 Supplement to 090037 Lactinex Haley’s M-O

Supplement to 090090 Supplement to 090061

Ophthalmic Administrative File OTC Ophthalmic Drug Products (Docket No. 80N-0145)

VOLUME 100001 100002 100003 100004 100005 100006 100007 100008 100009 100011 100012 100013 100014 100015 100016 100017 100018 100019

SUBMITTED BY Flow Pharmaceuticals, Inc. Riker Laboratories, Inc. Julius Schmid, Inc. Julius Schmid, Inc. Abbott Laboratories Burton, Parsons & Company, Inc. Burton, parsons & Company, Inc. Burton, parsons & Company, Inc. Norwich Pharmacal Company Wyeth Laboratories, Inc. Professional Pharmacal Company Professional Pharmacal Company Professional Pharmacal Company Professional Pharmacal Company Barnes-Hind Pharmaceuticals, Inc. Pfizer Pharmaceuticals

TRADE NAME/SUBJECT Hy-Flow, aqua-Flow, Comfy, duoFlow, d-Film, Trilisol Bro-Lac, Op-Isophrin, Wet-Tone Eyegenic Eye Mist Eye-Gene Eye Drops Murine Adsorbonac 2% Adsorbonac 5% Soothe Ocusol Eye Lotion, Ocusol eye Drops Collyrium Soothing eye Lotion, Collyrium with Ephedrine Soothing Eye Drops Bufopto Zinc Sulfate Efricel 1/8% Neozin Methulose, Visculose Degest Visine Eye Drops

100020 100021 100022 100023 100027 100030 100031 100032 100033 100034 100035 100036 100037 100038 100039 100040 100041 100043 100044 100045 100046 100047 100048 100050 100051 100052 100053 100054 100055 100056

Alcon Laboratories, Inc. Alcon Laboratories, Inc. Alcon Laboratories, Inc. Alcon Laboratories, Inc. Alcon Laboratories, Inc. Alcon Laboratories, Inc. Alcon Laboratories, Inc. Alcon Laboratories, Inc. Alcon Laboratories, Inc. LaWall & Harrisson Research laboratories, Inc. Abbott Laboratories Cooper Laboratories, Inc.

Contique Contact Lens Wetting Solution, Lens-Mate Isopto Frin Naphcon Op-Thal-Zin Contique Artificial Tears Zincfrin Estivin Isopto Tears, Ultra Tears Eye-Stream 20/20 Eye Drops Clear Eyes Argyrol S.S., Goniosol, M-Z, Phenylzin, Tear-Efrin, Tearisol Lacril Lacri-Lube S.O.P. Ocu-Drop Stye Ocu-Bath Contique Artifical Tears Additional Data Pre-Sert murine Additional Data Contique Dual-Wet Solution Lens-Mate Tears naturale’ Mitchum’s Eye Drops Test Method Used for All Purpose Contact Lens Solutions Total

Allergan Pharmaceuticals Allergan Pharmaceuticals Commerce Drug Company, Inc. Commerce Drug Company, Inc. Commerce Drug Company, Inc. Alcon Laboratories, Inc. Allergan Pharmaceuticals Abbott Laboratories Alcon Laboratories, Inc. Alcon Laboratories, Inc. Alcon Laboratories, Inc. Mitchum-Thayer, Inc. Proprietary Association Allergan Pharmaceuticals

100057

Schering Corporation

Documentation in Support of Methylparaben and Propylparaben Comination Documentation in Support of Sodium Thiosulfate Documentation in Support of Tyloxapol General Guidelines Applicable to the Evaluation of Lens Care Products Blink-N-Clean Liquifilm Liquifilm Tears Prefrin Liquifilm Eye Drops Prefrin-Z Liquifilm Comments and Recommendations on Panel’s Summary Minutes Comments and Recommendations on Panels’s Summary Minutes Additional Comments on Cleaning and Wetting Agents hy-Flow, aqua-Flow, Comfy, duoFlow, d-Film, Trilisol Additional data Comment on 10% Sulfacetamide and 2.3% Sodium Chloride Solution Supplemental Data on Cleaning and Wetting Agents Additional Studies Regarding Benzalkonium Chloride Comments on Warnings and Labeling Additional Information on “Preservative information” Safety Protocol for 0.05% Naphazoline Cytochemical Methods Data on “Draize” Testing Ethylene Oxide Testing, and Buffering Estivin Additional Data Letter to Panel on Stye Ointment Supplemental Information on Ocusol Eye Lotion and Comment on Eye Wash and Eye Lotion Clerz

100058 100059 100060 100061 100062 100063 100066 100067 100068 100069 100070 100071 100072 100073 100074 100075 100076 100078 100079 100080 100081 100082 100083 100084

Alcon Laboratories, Inc. Allergan Pharmaceuticals Allergan Pharmaceuticals Allergan Pharmaceuticals Allergan Pharmaceuticals Allergan Pharmaceuticals Allergan Pharmaceuticals Alcon Laboratories, Inc. Alcon Laboratories, Inc. Flow Pharmaceuticals Schering Corporation Alcon Laboratories, Inc. Alcon Laboratories, Inc. Allergan Pharmaceuticals Allergan Pharmaceuticals Norcliff Thayer, Inc. K.C. Tsou, Ph.D. University of Pennsylvania Allergan Pharmaceuticals Alcon Laboratories, Inc. Woody D. Davis, M.D. Meridian, Mississippi Norwich Pharmacal Co. Flow Pharmaceuticals

100085 100086 100087

Alcon Laboratories, Inc. U.S.V. Pharmaceutical Corp. Allergan Pharmaceuticals

100088 100089 100090 100091 100092 100093 100094 100095 100096 100097 100098 100099 100100

Alcon Laboratories, Inc. Schering Corporation

Supplemental Information on Hydroxypropylmethyl-cellulose Supplemental Information on 0.05% Naphazoline Methodology for testing Safety, Effectiveness of Hard Contact Lenses. Data for Polyethylene glycol, Polyoxylstearate, Polysorbate. Volumes 1 and 2 Benzalkonium Chloride as a Preservative Sulffacetamide Data

U.S.V. Pharmaceutical Corp. Allergan Pharmaceuticals Ketchum Laboratories Calvin Hanna Allergan Pharmaceuticals Alcon Laboratories, Inc. Alcon Laboratories, Inc.

Naphazoline Data: Dr. S. Morgan, Galin, U.S.V. Letter October 21, 1975 Polyvinyl Alcohol Data on Effectiveness as Wetting Agent Comments on Preservative Test Guidelines Data on 0.05% Naphazoline Data on the use of Sodium Citrate in Lacril and Liquidifilm Forte Estivin Additional Data Collaborative Industry Study on the Effect of Serum on the Preservative Effectiveness of Hard Contact Lens Solutions Transcript of Presentation to Panel on Stye Ointment Statement on FDA Policy on Exclususivity of Labeling Terms Recommendation to the Panel to Allow Flexibility to Adjust Osmolarity for Ophthalmic Products and Expansion of the List of Acceptable Polyethylene Glycols Aqueo-Rinse, Dual-Clean Pena-Vel, Stay-Brite, Stay-Wet, Velva-Kleer Study on the Safety and Efficacy of Mercuric Oxide Ointment for Relief of Sties and Minor Infections of the Eyelids Comments and Recommendations on Panel’s Report OTC Drug Literature Program Ophthalmic Preparations Additional Information on Mild Silver Protein as an Anti-infective Comments on Panel’s Summary Minutes

100101 101102 100103

Woody D. Davis, M.D. Meridian, Mississippi Proprietary Association Cooper Laboratories, Inc.

100104 100105

Sherman Laboratories, Inc. Commerce Drug Company, Inc.

100106 100107 100108 100109

Proprietary Association Medical Library Cooper Laboratories, Inc. Cooper Laboratories, Inc.

100110 100111

Cooper Laboratories, Inc. William H. Havener, M.D.

Polyethylene Glycol Additional Information Comments on Madatory OTC Drug Labeling

Public Administrative File OTC Ophthalmic Drug Products (Docket No. 80N-0145) Alphabetical Listing of References Cited in Report
VOLUME 100112 100113 100114 100115 100116 100117 100118 100119 100120 100121 100122 100123 100124 100125 CONTENTS A-B C-D E-G H-J K-M N-R O: “Ophthalmology Prescription Handbook” (only) S T-Z Miscellaneous Uncited References: A - E Miscellaneous Uncited References: F - H Miscellaneous Uncited References: I - R Uncited References: S: Smith, R.B. editor, “Anesthesia in Ophthalmology” (only) Miscellaneous Uncited References: S - Z

Administrative File OTC Ophthalmic Drug Products Docket No. 80N-0145 Panel Administrator’s File

VOLUME 10APA1

CONTENTS Panel Administrator’s File, Volume I - General 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General and Specific Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment Panel Administrator’s File, Volume II - Minutes of Panel Meetings. Panel Administrator’s File, Volume III - Correspondence File, (1973-1980).

10APA2 10APA3

OTC CONTRACEPTIVE SUBMISSIONS (149A/0080A) October 26, 1979

VOLUME 110001

FIRM Center for Science in the Public Interest Washington D.C. 20036 FDA

PRODUCT OR DATA Talc

PRODUCT LABELED INGREDIANTS

Literature Search DESI publications Koromex Contraceptive Jelly, Koromex Contraceptive Cream, Korpmex Contraceptive Jelly Boric acid, phenylmercuric acetate “ ” “ ”

110004

FDA Holland Rantos Co., Inc. Trenton, NJ 08854

110005 110006 110007 110012/14

Ortho Pharmaceutical Corp. Raritan, NJ 08869 Ortho Pharmaceutical Corp. Raritan, NJ 08869 Ortho Pharmaceutical Corp. Raritan, NJ 08869 Norwich Pharmacal Co. NY 13815 Norwich Pharmacal Co. NY 13815

Ortho Gynol Contraceptive Jelly Preceptin Contraceptive Gel Ortho-Creme Contraceptive Cream Lorophyn jelly

Boric acid, polyoxyethylene nonyl phenol, phenyl-mercuric acetate p-Diisobutylphenoxypolyethoxyethanol p-Diisobutylphenoxypolyethoxyethanol Nonoxynol-9 PMA, octoxynol, methylparaben, sodium borate PMA, methylbenzethonium chloride, methylparaben methoxypolyoxyethylene glycol 550 Laurate Nonyl phenoxypolyethoxy ethanol. methoxypolyoxyethylene glycol 550 Laurate, nonoxynol-9 Methoxypolyethylene glycol 550 laurate, nonoxynol-9

Lorophyn Contraceptive Suppositories Immolin Contraceptive Vaginal Cream - Jel

110016

Juluis Schmid, Inc. New York, NY 10019

110017

Juluis Schmid, Inc. New York, NY 10019 Juluis Schmid, Inc. New York, NY 10019

Finesse Contraceptive Creme - gel Finesse Contraceptive Creme - Gel

110018

110020 110021 110026 110028A 110030

Juluis Schmid, Inc. New York, NY 10019 Holland Rantoes Co., Inc. Piscataway, NJ 08854 Ortho Research Foundation Raritan, NJ 08869 Schmid Laboratories Little Falls, NJ 07424 Schmid Laboratories, Little Falls, NJ 07424 Ortho Pharmaceutical Corp. Raritan, NJ 08869 “ ” “

Ramses Contraceptive Vaginal Jelly Improved Koromex Contraceptive Jelly Selective Bibliography on Vaginal Contraception and Therapeutics Supp’l data; Vagesic, Ramses jelly, Immolin cream - jel Supp’l data; Immolin and Finesse Contraceptives Rabbit Model preprint

Dodecaethylene glycol mono-laurate, boric acid, alcohol Laureth 10S

combo of methoxypolyoxyethylene glycol 550 Laurate and Nonoxynol - 9

110033

110036

Emko Company St. Louis, MO 63147

3 references lists re: spermphsiology and animal models for vaginal contraceptives. Emko contraceptive foam

nonyl phenoxy polyoxyethylene ethanol. Benzethorium chloride “ Menfegol ” “

110040/41 110045 110049 110050

Ortho Pharmaceutical Corp. Raritan, NJ 08869 Proprietary Assn. Wash., DC. 20006 Juliu Schmid, Inc. Nova Corp of America Cos Cob, CT 06807 FDA Ortho Research Foundation Raritan, NJ 08869 The Proprietary Assn. Washington, DC 20006 Whitehall Laboratories New York, NY 10017 FDA FDA

Because contraceptive foam Vaginal Contraceptive foaming tablet-safety and effectiveness OTC Labeling Indications Ramses Flavo-Cept. Contraceptive jelly Mercury Correspondence Selective Bibliography: 1975 Supplement to Volume 110026 Comments on the November 1978 “Information Copy” Panels Tentative Findings Semicid: labeling presentation December 7, 1978 Cited References (A-B) Cited References (C-F)

Dodecaethylene glycol monolaurate polyethylene glycol 600 monolaurate (PEG-12 Laurate, Dodecaethylene glycol monolaurate

110052 110053

110055

110056 110058 110059

Nonoxynol-9

110060 110061 110062 110063 110064

FDA FDA FDA FDA FDA

Cited References (G-K) Cited References (L-O) Cited References (P-S) Cited References (T-Z) Uncited References

Administrative File OTC Vaginal Contraceptive Drug Products Docket No. 80N-0280

Panel Administrator’s File
VOLUME 11APA1 CONTENTS Panel Administrator’s File, Volume I - General 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Interim Recommendation on Encare Oval 1.7 Regulatory Analysis Assessment 1.8 Statement of Exemption and Environmental Assessment Report 1.9 Requests for Confidentiality Panel Administrator’s File, Volume II - Minutes of Panel Meetings Panel Administrator’s File, Volume III Correspondence File (1973-1974) Panel Administrator’s File, Volume IV Correspondence File (1975-1977) Panel Administrator’s File, Volume V Correspondence File (1978)

11APA2 11APA3 11APA4 11APA5

11APA6

Panel Administrator’s File, Volume VI Correspondence File (1978-1979)

VAGINAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ADMINISTRATIVE RECORD (DOCKET NO. 82N-0291) INDEX TO PANEL SUBMISSIONS
OTC VOLUME NUMBER 110001 SUBMITTED BY Center for Science in the Public Interest FDA FDA Reed & Carnrick Pharmaceuticals McKesson Laboratories Chattem Drug & Chemical Company Rystan Company Bristol-Myers Company Block Drug Company Boyle and Company Juluis Schmid, Inc. SUBJECT Talc Literature Search DESI Publications Tricotine Powder Tricotine Liquid V.A. Douche Powder Mata-Cine Concentrated Douche Powder Pamprin Concentrated Douche Powder Prophyllin Powder Feminique Douche Liquid Concentrate Femicare Powder Triva Douche Powder Vagesic Douche Liquid Concentrate

110002 110003 110008

110009 110010 110011 110015 110019

110022

Meri Jo. Inc. G.M. Case Laboratories Phenex Laboratories, Inc.

110023 110024 110025 110027 110028B 110029

Purdue Frederick Company Norcliff Laboratories, Inc. Beecham, Inc. Wyeth Laboratories, Inc. Chattem Drug & Chemical Company Louis Keit h, M.D. Beecham, Inc. Purdue Frederick Company Rystan Company Wyeth Laboratories, Inc. Young’s DrugProducts R. Schattner Company Beecham, Inc. Ortho Pharmaceutical Corporation

Fine’s Hygienic Powder PAF Douche Powder Complete Feminine Hygiene Antiseptic Deodorant Douche Phenex Feminine Hygiene Antiseptic Phenex Vaginal Therapeutic Suppositories Phenex Hygienic Suppositories Betadine Douche Zonite, Zonitors Massengill Liquid Douche Propion Gel Meta-Cine and Pamprin Douche Powders Vaginal Odors Preprint and References Intravaginal Administration of Boric Acid Betadine Douche Prophyllin Douche Propion Gel Polysorbate 20 as a Douche Gynaseptic Vaginal Solution Gynaseptic Vaginal Ointment Boric Acid Rabbit Model Preprint Vaginal ph References Guide to the Physiological Suitability of Atlas Surfactants Cleansing Properties of Pluronic F-68 Surfactants as Vaginal Douches Three Reference Lists Re: Sperm Physiology and Animal Models for Vaginal Contraceptives Polysorbate 20 Safety Data Douche Pipe Design and Minimum Volume for Cleansing Talc Pressure Effects of Douching Douche Powders Vagistat Vaginal Douche Boric Acid/Sodium Borate OTC Labeling Indications Povidone-Iodine

110031 110032 110033

110034 110035 110037 110038 110039 110042/43 110044 110045 110046/48

International Playtex, Inc. Vick Divisions Research Cosmetic, Toiletry, and Fragrance Association Foster D. Snell Reed & Carnrick Pharmaceuticals Aloe Vera of America U.S. Borax Research Corporation Proprietary Association GAF Corporation

110051 110054 110055 110057 110065 110066 110067 110068 110069 110070 llBPAI llBPAII(See llAPA2) llBPAIII llBPAIV llBPAV

Purdue Frederick Company GAF Corporation Proprietary Association GAF Corporation

Betadine Douche Povidone-Iodine Comments on Panel’s November 1978 Tentative Findings “Information Copy” Povidone-Iodine Cited References (A - D) Cited References (E - J) Cited References (K - P) Cited References (Q - T) Cited References (U - Z) Uncited References Panel Administrator’s File (1.1 - 1.5) Panel Administrator’s File (Minutes of Panel Meetings) Panel Administrator’s File (Correspondence 1973 - 1975) Panel Administrator’s File (Correspondence 1976 - 1977) Panel Administrator’s File (Correspondence 1978 - 1979)

HEMORRHOIDAL (ANORECTAL) PANEL INDEX (12)

VOLUME 120001 120002 120003 120004 120005 120006 120007 120008 120009 120010 120011 120012 120013 120014 120015 120016 120017 120018 120019 120020 120021 120022 120023 120024 120025 120026 120027 120028

SUBMITTED BY Upjohn Upjohn Astra Warner-Chilcott Resinol Chemical Company Wyeth Labs Whitehall Whitehall Whitehall Ciba-Geigy Ciba-Geigy Chesebrough-Pond’s Sterling Drug Winthrop Labs. Div Sterling Drug Winthrop Labs. Div. Abbott Combe Quist Chemical Phenex Combe Fuller Pfizer Whitehall Ciba-Geigy Ciba-Geigy Sterling Drug Winthrop Labs. Div. Merrell-National Sterling Drug Ciba-Geigy Sterling Drug

SUBJECT Tanicaine Rectal Ointment and Suppositories Epinephricaine Xylocaine 2.5% & 5% Ointment Anusol Suppositories and Ointment Resinol Greaseless Cream Wyanoids Suppositories Wyanoid Ointment Protegel Preparation H Ointment and Suppositories Volume I Preparation H Ointment and Suppositories Volume II Preparation H Ointment and Suppositories Volume III Nupercainal Ointment and Suppositories Volume I Nupercainal Ointment and Suppositories Volume II Vaseline Pontocaine Cream and Ointment Volume I PNS Suppositories Volume II Tronothane Lanacane Creme Quist Ointment Phenex Rectal Suppositories Lanacane Creme Tucks Benzyl Alcohol Live Yeast Cell Derivative Nupercainal Ointment and Suppositories Nupercainal Ointment and Suppositories PNS Suppositories Diothane Ointment Tyloxapol Nupercainal Ointment and Suppositories PNS Suppositories

120029 120030 120031 120032 120033 120034 120035 120036 120037 120038 120039 120040 120041 120042 120043 120044 120045 120046 120047 120048 120049 120050 120051 120052 120053 120054 120055 120056 120057 120058

Dow Chemical Dr. Kade Pharmazeutische Bristol-Myers Whitehall Fuller Humphreys Bristol-Myers Dr. Kade Pharmazeutische Bristol-Myers Combe Reed & Carnrick Ciba-Geigy Ciba-Geigy Ciba-Geigy Phenex Combe Bristol-Myers Philips-Roxane Combe Combe Combe Reed & Carnrick Various Sources Chesebrough-Pond’s Bellwood Pharmaceutical University of Nebraska Medical Center Astra Proprietary Association Schwarting Proprietary Association

Dyclone Creme Posterisan Pazo Ointment and Suppositories Skin Respiratory Factor Tucks Hamamelis Water Medicated Anal Wipe Foam Posterisan Aerosol Medicated Anal Wipe Foam Resorcinol Non-Steroid Proctofoam Nupercainal Ointment and Suppositories Nupercainal Ointment and Suppositories Nupercainal Ointment and Suppositories Phenex Resorcinol Combination Policy Remarks Gentz Wipes Lanacane Creme Resorcinol Resorcinol Non-Steroid Proctofoam Unpublished References Vaseline Hemozone Camphor Xylocaine Ointment Criteria For Placing Category III Ingredients in Category I Lappa/Leptandra Collinsonia Combination Policy Statement

120059 120060 120061 120062 120063 120064 120065 120066 120067 120068 120069 120070 120071 120072 120073 120074 120075 120076 120077 120078 120079 120080 120081 120082 120083 120084 120085 120086 120087 120088 120089

Dow Chemical Whitehall Dr. Trunkey American Home Products Chesebrough-Pond’s Ciba-Geigy Reed & Carnrick Warner-Chilcott Malmstrom Chemicals Merrell-National American Home Products Ciba-Geigy Ciba- Geigy Arnar-Stone Merrell-National Proprietary Association Merrell-National Ciba-Geigy Ciba-Geigy Ciba-Geigy Schuylkill Chemical Proprietary Association Ciba-Geigy Whitehall Whitehall Abbott Merrell-National Merrell-National Proprietary Association Astro-Solar Boston University

Dyclone Creme 1% Skin Respiratory Factor Donor Site Wound Study Skin Respiratory Factor Vaseline Nupercainal Ointment and Suppositories Non-Steroid Proctofoam Anusol Suppositories Lanolin and its Derivatives Diothane Ointment Skin Respiratory Factor Nupercainal Ointment and Suppositories Nupercainal Ointment Protocol Benzocaine Diothane Ointment/NDA 1-941 Combination & Testing Policies Comments Diothane Ointment Nupercainal Ointment and Suppositories Nupercainal Ointment and Suppositories Nupercainal Ointment Allantoin & Alcloxa Comments on Panel’s Draft Report Released December 1977 Nupercainal Suppositories Skin Respiratory Factor Miscellaneous Hemorrhoidal Product Labeling Tronothane Cream & Jelly Diothane Ointment Volume I Diothane Ointment Volume II Combination & Testing Policies (Same as Volume 120074) Tengum Nupercainal Ointment and Suppositories

120090 120091 120092 120093

Ciba-Geigy Chesebrough-Pond’s Whitehall Whitehall

Transcript of 5/3/75 Meeting Corrections of Summary Minutes of 27th Meeting of Hemorrhoidal Panel Skin Respiratory Factor Presentation Skin Respiratory Factor Presentation (References)

Alphabetical Listing of REFERENCES CITED in Report
VOLUME 120094 120095 120096 120097 120098 120099 120100 120101 120102 CONTENTS A B C D-F G-J K-N O-R S T-Z

Alphabetical Listing of REFERENCES NOT CITED in Report
VOLUME 120103 120104 120105 120106 120107 120108 CONTENTS A-B C-D E-G H-K L-O P-Z

ADMINISTRATIVE FILE OTC ANORECTAL DRUG PRODUCTS DOCKET NO. 80N-0050 PUBLIC ADMINISTRATOR’S FILE
VOLUME 12APA1 CONTENTS Panel Administrator’s File, Volume I - General 1.1 Call for Data 1.2 List of Panel Memebers and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exemption and Environmental Assessment Report Panel Administrator’s File, Volume II - Minutes of Panel Meetings. Panel Administrator’s File, Volume III Correspondence File (1972-1980)

12APA2 12APA3

Public Administrative File OTC Oral Health Care Drug Products (Docket No. 81N-0033)
VOLUME 130001 130002 130003 130004 130005 130006 130007 130008 130009 130010 130011 130012 130013 130014 130015 130016 130017 130018 130019 130020 130021 130022 130023 130024 130025 130026 130027 130028 130029 130030 130031 SUBMITTED BY Monsanto Henry Thayer Co. Lorvic Corp. Hoyt Cox Drugs Denver Chemical Manufacturing Co. Merrell-National Laboratories Merrell-National Laboratories Merrell-National Laboratories Endo laboratories, Inc. Upjohn Endo Laboratories, Inc. Rystan Co., Inc. International Pharmaceutical Corp. Endo Laboratories, Inc. Richardson-Merrell, Inc. TRADE NAME/ SUBJECT Methyl Salicylate Thayers Slippery Elm Throat lozenges Odara Solution Orabase with Benzocaine Formula “U” Pain-A-Lay Cepacol Mouthwash/Gargle Cepacol Throat Lozenges Cepacol Anesthetic Troches Benocol Oral Pentacresol Lidocol Chloresium Gly-oxide Liquid Dyclocol Vicks Medi-Trating Lozenges Vicks Oracin Throat Lozenges Arm and Hammer Baking Soda Cheramist Sucrets Cough Control Lozenge Sucrets Sore Throat Lozenge

Church and Dwight Co., Inc. K.I.K. Calgon Consumer Products Co., Inc. Calgon Consumer Products Co., Inc.

130032 130033 130034 130035 130036 130037 130038 130039 130040 130041 130042 130043 130044 130045 130046 130047 130048 130049 130050 130051 130052 130053 130054 130055 130056 130057 130058

Calgon Consumer Products Co., Inc.

Sucrets Cold Decongestant

Block Drug Co., Inc. Block Drug Co., Inc. Warren-Teed Warner-Lambert Co.

Proxigel Chloraseptic Di-O-Chrome Listerine Antiseptic

Cooper Laboratories, Inc. Ciba-Geigy Corp. Ayerst laboratories Julius Schmid, Inc. Johnson and Johnson Purdue Frederick Co. Blair Laboratories, Inc. E.R. Squibb and Sons, Inc.

Amosan Domiphen Bromide Larylgan Throat Spray Comments Micrin Plus Gargle and Rinse Betadine Isodine Concentrate Spec-T Decongestant Lozenges Spec-T Cough Suppressant Spec-T Anesthetic Lozenges Spec-T Throat Spray Anesthetic, Aqueous and Concentrate Mouthwash, and Aerosol Spray Scott’s Certified Peroxide of Hydrogen Anesthetic Gargle/Rinse/Spray Chloraseptic Gly-oxide Liquid Cepacol Mouthwash/Gargle Cepacol Lozenges Cepacol Troches Cepacol Discs Spec-T Sore Throat/Decongestant Lozenge Spec-T Sore Throat/Cough Suppressant Lozenge Spec-T Sore Throat/Anesthetic Lozenge

130059 130060 130061 130062 130063 130064 130065 130066 130067 130068 130069 130070

Block Drug Co., Inc. Scott Laboratories, Inc. Merrell-National Laboratories Block Drug Co., Inc. International Pharmaceutical Corp. Merrell-National Laboratories

E.R. Squibb and Sons, Inc.

130071 130072 130073 130074 130075 130076 130077 130078 130079 130080 130081 130082 130083 130084 130085 130086 130087 130088 130089 130090 130091 130092 130093 130094 130095 130096 130097 130098 130099 130100 130101

Cooper Laboratories, Inc. Schmidt Laboratories McKesson Laboratories Warner-Lambert Co. Hynson, Westcott, and Dunning, Inc. LaWall and Harrison Research laboratories, Inc. Reed and Carnrick Pharmaceuticals Procter and Gamble Co. Calgon Consumer Products Co., Inc. Reed and Carnrick Pharmaceuticals Whitehall Laboratories Reed and Carnrick Pharmaceuticals International Pharmaceutical Corp. Cooper Laboratories, Inc. The Proprietary Association Sterling Drug, Inc. Ryatan Co., Inc. Merrell-National Laboratories Bernard L. Oser Associates, Inc. Warner-Lambert Co. Cooper Laboratories, Inc.. Cooper Laboratories, Inc. Richardson-Merrell, Onc. Warner-Lambert Co. Panelist Martin J. Goldberg, D.D.S. Cooper Laboratories, Inc. Industry Liaison Joseph D. Ambrozaitis, D.D.S., Ph. D. Sterling Drug, Inc.

Amosan Comments Isodettes Throat Lozenges Listerine Throat Lozenges Thantis Lozenges Troutman’s Cough Syrup Anesthetic Mouthwash Scope Mouthwash and Gargle Sucrets Sore Throat Lozenges Anesthetic Mouthwash Anbesol Benzocaine Spray Gly-oxide Liquid Oral-B Antiseptic Drops Journal of Periodontal Research, Supplement No. 14, 1975 Campho-Phenique Liquid Campho-Phenique Powder Choresium - Data Supplement to Volume 130015 Cepacol - Addendum to Volume 130007 Statement Data to Volume 130042 Supplemental Data to Volume 130042 Supplemental Dat - “Actions of Oxygenating Agents on Oral Inflamations” Supplement to Volume 130085 Oral-B Antiseptic Drops Vicks Throat Lozengers Supplement to Volume 130019 Supplemental Data to Volume 130042 Three Papers from V. Periodontology, Volumes 45-46 Amosan - Upadate of Data and Information to Volumes 130048, 130071, 130085, and 130093 Bibliography: “A Review of mal Odor” Campho-Phenique - Addendum to Volume 130087.

130102 130103 130104 130105 130106 130107 130108 130109 130110-A 130110-B 130111 130112 130113 130114

Colgate-Palmolive Co. The Proprietary Association Plough, Inc. Sterling Drug, Inc. Richardson-Merrell, Inc. Warner-Lambert Co. The Proprietary Association American Association of Poison Control Centers The Proprietary Association The Proprietary Association Cooper Laboratories, Inc. BASF Wyandotte Corp. Richardson-Merrell, Inc. Richardson-Merrell, Inc.

Benzethonium Chloride Mouthrinse Letter of June 26, 1976 and Position Paper - Rationale for Establishing Antiseptic Activity Mouthrinses Aspergum Campho- Phenique - Supplement to Volume 130087 Cepacol Professional labeling for Mouthwash Gargle, Throat Lozenges, Anesthetic Troches Listerine - Supplement to Volume 130042 Letter on Mouth-odors Letter on Camphor Statement on Combining Multiple Ingredients Statement on the Evaluation of Mouthrinses Amosan - Supplemental Information to Volumes 130048, 130071, 130085 and 130093 Pluronic Polyols - Toxicity and irritation Data Metholated Cough Drops Updating Information to Volume 130019 Letter Relevant to the Panel’s Invitro Guidelines for an Antiseptic/Antimicrobial Mouthwash Benzethonium Chloride Supplemental Data to Volume 130102 Oracin Throat Lozenges Supplemental Data to Volume 130020 OTC Oral Topical Antiseptics Addendum to Volume 130078 Additional Data OTC Combinations Benzethonium Chloride Supplemental Data to Volume 130102 Addendum to Volume 130042 Cepacol Concentrate - Labels for Dental Decanter and Gallon Bottle Oral B Antiseptic Drops Supplemental Information to Volume 130048 Menthol - Additional Data to Volume 130019

130115 130116 130117 130118 130119 130120 130121 130122 130123 130124

Colgate-Palmolive Co. Richardson-Merrell, Inc. The Proprietary Association Procter and Gamble Co. The Proprietary Association Colgate-Palmolive Co. Warner-Lambert Co. Richardson-Merrell, Inc. Cooper Laboratories, Inc. Richardson-Merrell, Inc.

130125 130126 130127 130128 130129 130130-A 130130-B 130131 130132 130133 130134 130135 130136 130137 130138 130139 130140 130141 130142

Warner-Lambert Co. Warner-Lambert Co. Beecham Products Beecham Products Beecham Products Beecham Products Beecham Products Norwich Pharmacal The Proprietary Association The Proprietary Association Procter and Gamble Co. Warner-Lambert Co. Warner-Lambert Co. Warner-Lambert Co. Merrell-National Laboratories Cooper Laboratories, Inc. Warner-Lambert Co. The Proprietary Association The Proprietary Association

Listerine - Additional Data to Volume 130042 Listerine - Additional Data to Volume 130042 Dyclonine Lozenges Dyclonine Lozenges Dyclonine Lozenges Dyclonine Lozenges Dyclonine Lozenges Chloraseptic Products - Additional Data to Volume 130038 The Effectiveness of Locally Applied Topical Anesthetics Guidelines for the Evaluation of Mouthwashes for the Reduction of Intrinsic Oral Malodor Cetylpyridinium Chloride and Domiphen Bromide Data Listerine Antiseptic Listerine Antiseptic Listerine Antiseptic Cepacol Mouthwash/Gargle Amosan Listerine Antiseptic - Volatile Oils/Topical In-vitro Evaluation of Antimicrobial Mouthrinses In-vitro Evaluation of Antimicrobial Mouthrinses - Volumes 1,2, and 3 Comments to the panel’s Draft Report Sore throat Product Labeling In-vitro Antimicrobial Testing Guidelines “Bad Breath” Oracin Throat Lozenges Statistical Evaluation of Studies on Cepacol and Scope Statistical Analysis of Listerine Antiseptic Drug Efficacy Study

130143 130144 130145 130146 130147 130148 130149

Beecham Products Lever Brothers Co. Oral Products Hedonics Richardson-Merrell, Inc. Ralph B. D’Agostino Ralph B. D’Agostino Division of Medical Sciences, National Research Council/National Academy of Sciences Merrell-National Laboratories

130150

Effects of Local Anesthetics on Tactile Sensitivity Thresholds for Cutaneous and Mucous Membranes

130151 130152 130153

Merrell-National Laboratories Cooper Laboratories, Inc. Marion Laboratories

Cetylpyridinium Chloride/Sodium Fluoride Solution Amosan Guidelines for Testing the Effectiveness of Locally Applied Topical Antiseptics Other Than Mouthrinses Thantis Lozenges (was 170040) The Efficacy of Mouthwashes Listerine Amosan Amosan “Absorption of Boron after Mouthwash Treatment with Bocosept” Active Ingedients in Scope Cetylpyridinium Chloride and Domiphen Bromide Information Provided to Dr. D’Agostino for Statistical Evaluation Information Pertaining to a Presentation by the Proprietary Association to the Panel Effectiveness of Locally Applied Topical Antiseptics Listerine Antiseptic - Drug vs Cosmetic Claims/Comment on Draft Report Safety and Effectiveness of Cetylpyridinium Chloride Safety and Effectiveness of Cetylpyridinium Chloride Safety and Effectiveness of Cetylpyridinium Chloride Safety and Effectiveness of Cetylpyridinium Chloride Safety and Effetiveness of Cetylpyridinium Chloride Safety and Effectiveness of Cetylpyridinium Chloride Safety and Effectiveness of Cetylpyridinium Chloride Relationship between Plaque, Bacteria, and Oral Disease In-vitro and In-vivo Testing of Antiseptic Mouthrinses Dental Plaque - Gingivitis and Dental Caries Methods for Measuring Plaque

130154 130155 130156 130157 130158 130159 130160 130161 130162 130163 130164 130165 130166 130167 130168 130169 130170 130171 130172 130173 130174 130175

Hynson, Wescott, and Dunning, Inc. Panelist Arthur N. Bahn, Ph.D. Warner-Lambert Co. Cooper Laboratories, Inc. Cooper Laboratories, Inc. Cooper Laboratories, Inc. Procter and Gamble Co. Procter and Gamble Co. The Proprietary Association The Proprietary Association Warner-Lambert Co. Merrell-National Laboratories Merrell-National Laboratories Merrell-National Laboratories Merrell-National Laboratories Merrell-National Laboratories Merrell-National laboratories Merrell-National Laboratories Warner-Lambert Co. Walter J. Loesche, D.M.D., Ph. D Procter and Gamble Co. Forsyth Dental Center

130176 130177 130178 130179 130180 130181 130182 130183 130184 130185 130186 130187 130188 130189 130190 130191 130192 130193

Purdue Frederick Co. Whitehall Laboratories, Inc. Louis P. Gangerosa, Sr., D.D.S. Warner-Lambert Co. Plough, Inc. Nathaniel H. Rowe, D.D.S. The Proprietary Association Purdue Frederick Co. Panelist Arthur N. Bahn, Ph. D. Irwin D. Mandel, D.D.S. Cooper Laboratories, Inc. Procter and Gamble Co. The Proprietary association Panelist Walter E. Loch, M.D. The Proprietary Association University Faculty Members Panel Chairman Lawrences Cohen, Ph. D., M.D., D.D.S. D. B. Smith, D.D.S.

Povidone-Iodine Anbesol Comments Listerine Topical Analgesics (Asprin) and Sore Throat Comments - Dental Plaque Soft Tissue Responses to High Frequency Use of Experimental and Commercial Mouthwashes Providone-Iodine - Testing Minority Report, OTC advisory Panel on OTC oral Cavity Drug Products Plaque and Dental Disease Amosan Domiphen Bromide Alone and in Combination with Cetylpyridinium Chloride Comments on the Information Copy of the panel’s Report Comments on Monograph Comments on “Methods of Expressing Strength of Drugs” Comments on Plague, Gingivitis, or Microbial Activity in the Mouth as Related to OTC Mouthwashes Statement to the OTC Panel Clarification of Data in his Paper on Mouthwashs and Oral Cancer

Public Administrative File OTC Oral Health Care Drug Products (Docket No. 81N-0033) Alphabetical Listing of References Cited in the Report
VOLUME 130194 130195 130196 130197 130198 130199 130200 130201 130202 130203 130204 130205 130206 CONTENTS A B C D-E F-G H-J K-L M-N O-R S T-Z Miscellaneous Uncited References A-G Miscellaneous Uncited references H-Z

Public Administrative File OTC Oral Health Care Drug Products (Docket No. 81N-0033) Panel Administrator’s File
VOLUME 130PA1 CONTENTS Panel Administrator’s File Volume I - General 1.1 Calls for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae for Panel Memebrs and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index of Panel Submissions Panel Administrator’s File, Volume II - Minutes of Panel Meetings Panel Administrator’s File, Volume III - Correspondence File (1973-1982).

130PA2 130PA3

File

July 7, 1975

Panel Administrator OTC Division Zirconium Report 75N-0003

The following volumes of data were hand-carried to Room 14-65 this date:
VOLUME 140032 140034 140035 140036 140037 140038 140039 140042 140043 140046 140048 140049 140050 140000 Proctor & Gamble - Secret, Sure Proctor & Gamble Proctor & Gamble Proctor & Gamble Proctor & Gamble Proctor & Gamble Proctor & Gamble Carter-Wallace - Arrid XX Gillette A - Correspondence File B - Summary Minutes - Antiperspirant Panel C- References SUBJECT Carter-Wallace Carter-Wallace Gillette - Right Guard Extra Strength

Docket Number 75N-0003 has been assigned by the Hearing Clerk for the Zirconium Report. Lee Geismar ANTIPERSPIRANT OTC DRUGS DATA AND INFORMATION

VOLUME 140001-3 140004 140005 140006 140007 140008 140009

SUBMITTED BY Gillette Gillette Gillette Gillette Gillette Gillette Gillette

TRADE NAME Right Guard Antiperspirant Right Guard natural Scent Antiperspirant Right Guard Powder Dry Antiperspirant Soft & Dri Lightly Powdered Antiperspirant Deodorant Soft & Dri Unscented Antiperspirant Soft & Dri Scented Antiperspirant X-Hydra Antiperspirant Deodorant Liquid X-Hydra Antiperspirant Deodorant Liquid Dial Antiperspirant Aerosol Redfoot

INGEDIENTS AND CONCENTRATION 3.4% Al Chlorhydroxide 3.4% Al Chlorhydroxide 3.4% Al Chlorhydroxide 3.4% Al Chlorhydroxide 3.4 Al Chlorhydroxide 3.4 Al Chlorhydroxide 20% Active Al Chlorhydroxide 3.6% Al Chloride 5% Cetyl Alcohol 15% Active Al Chlorhydroxide 7.2% Aluminum Chloride 44% Alcohol 3.5% Al Chlorhydroxide 8-Hydroxyquinoline sulfate 0.75%, Aluminum Potassium Sulfate 1.5%, Salicylic Acid 20%, Boric Acid 10%, Magnesium Stearate 3.5% or 4.0% Al Chlorhydroxide Aluminum Chlorhydroxide 5.5% Al Chlorhydroxide complex Al Chlorhydroxide 4.20%

140010

Gillette

140011 140012

Armour-Dial Red Foot

140013

Aerosol Techniques Aerosol Techniques

Antiperspirant Spray Extra Dry Super Dri-Mist Heavy Duty Antiperspirant

Aerosol Techniques

Rite-Aid Extra Dry Antiperspirant Spray

140014

Reheis Reheis Reheis Reheis Reheis Reheis

Chlorhydrol Powder Chlorhydrol Solution Micro-Dry Ultrafine Micro-Dry Ultrafine Basic Aluminum Bromide Rehydrol

Al Chlorhydroxide Complex Al Chlorhydroxide complex 50% Al Chlorhydrate impalpable Al Chlorhydrate impalpable Basic Aluminum Bromide Al ChlorhydroxidePropylene Glycol Complex Sodium Aluminum Chlorhydroxy Lactate Sodium Aluminum Chlorhydroxy Lactate 40% Al Chlorhydroxide 20% Al Chlorhydroxide 20% Al Chlorhydrate 3%

Chloracel Solid Reheis Reheis 140015 Armour-Dial Armour-Dial 140016 Sterling Drug Chloracel Solution Dial Antiperspirant Roll-On (Scented) Dial Antiperspirant Roll-On (Unscented) Body All Powdery Spray Deodorant and Antiperspirant Dorothy Gray Antiperspirant Atomist Deodorant Dorothy Gray Spin RollOn Deodoorant Antiperspirant Givenchy Gentleman Antiperspirant Deodorant Spray Sterling Drug Sterling Drug Sterling Drug Sterling Drug Tussy Dry Antiperspirant Spray Tussy Roll-On Deodorant Tussy Roll-On Deodorant Extra Strength Tussy Roll-On Deodorant (Unscented)

Sterling Drug

Al Chlorhydroxide 2% Alcohol 61% Al chlorhydroxide complex 20% Alcohol 25.17% Al Chlorhydrate 3%

Sterling Drug

Al Chlorhydrate Compound 3.36% Al Chlorhydrate 19.85% Al Chlorhydroxide 24% Al Chlorhydroxide 19.85%

140017

Sterling Drug Sterling Drug Sterling Drug Sterling Drug

Dorothy Gray Antiperspirant Cream Tussy Cream Deodorant Tussy Extra Strength Cream Deodorant Tussy Unscented Cream Deodorant Arrid Cream Arrid Cream with Chlorophyll Arrid Antiperspirant Roll-On Deodorant Light Powder Arrid Extra Dry Antiperspirant Spray Light Powder Arrid Extra Dry Unscented Antiperspirant Spray

Aluminum Sulfate 8.74% Aluminum Sulfate 8.74% Aluminum Sulfate 10.27% Aluminum Sulfate 8.74% Aluminum chlorhydrate 21.25% Aluminum chlorhydrate 21.25% Aluminum Chloride 1% Aluminum Sulfate 8% Sodium Aluminum Lactate 8% Water Soluble Lanolin Aluminum chlordrate 3.5% Aluminum Chlorhydrate 3.5%

140018

Carter Products Carter Products

140019

Carter Products

140020

Carter Products

Carter Products

140021

Texas Pharmacal Texas Pharmacal

Allercreme Aerosol Antiperspirant Deodorant Allercreme Aerosol Antiperspirant Deodorant (Unscented) Allercreme Antiperspirant Deodorant Creme Allercreme Antiperspirant Deodorant Creme (Unscented) Allercreme Liquid Spray Antiperspirant Deodorant Allercreme Liquid Spray Antiperspirant Deodorant (Unscented) Allercreme Roll-On Antiperspirant Deodorant Allercreme Roll-On Antiperspirant Deodorant (Unscented) Maxi-Dry HypoAllergenic Antiperspirant Roll-On Maxi-Dry HypoAllergenic Antiperspirant Roll-On (Unscented) Maxi-Dry HypoAllergenic Antiperspirant Cream Maxi-Dry HypoAllergenic Antiperspirant Cream (Unscented)

Aluminum chlorhydroxide 20% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 20% Alcohol 58% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 20% Aluminum Chlorhydroxide 25% Aluminum Chlorhydroxide 25% Aluminum Chlorhydroxide 25% Aluminum Chlorhydroxide 25% Zinc Phenolsulfonate

Texas Pharmacal

Texas Pharmacal

Texas Pharmacal

Texas Pharmacal

Texas Pharmacal Texas Pharmacal

Texas Pharmacal

Texas Pharmacal

Texas Pharmacal

Texas Pharmacal 140022 Carter Products

140023

USV Pharmaceutical

Mitchum Antiperspirant Spray Mitchum Antiperspirant Spray (Unscented) Mitchum Antiperspirant Spray Powder Mitchum Antiperspirant Spray Powder (Unscented) Mitchum Cream Antiperspirant Mitchum Antiperspirant Scented Liquid Mitchum Antiperspirant Unscented Liquid

Aluminum Hydroxychloride 2.8% Aluminum Chloride 1.4% Aluminum Hydroxychloride 2.8% Aluminum Chloride 1.4% Aluminum Hydroxychloride 3.5% Aluminum Hydroxychloride 3.5% Aluminum Chlorhydrol 19% Aluminum Chloride 4% Aluminum Chlorhydrol 14% Aluminum Chloride 7.3% Aluminum Chlorhydrol 14.98% Aluminum Chloride 7.79% Aluminum Chlorhydrol 14% Aluminum Chloride 7%

USV Pharmaceutical

USV Pharmaceutical USV Pharmaceutical

USV Pharmaceutical

USV Pharmaceutical

USV Pharmaceutical

USV Pharmaceutical

Mitchum Antiperspirant Stick

140024-29

Bristol-Myers Bristol-Myers

Ammens Foot Powder Ban Roll-On Antiperspirant Deodorant Unscented Ban Roll-On Antiperspirant Deodorant Ban Antiperspirant Cream Deodorant Ban Deodorant Spray

Aluminum Chlorhydrate 2% Aluminum Chlorhydrate 22% Aluminum Chlorhydrate Aluminum chlorhydroxide 18.4% Aluminum Chloride 3.6% Aluminum chlorhydrate 1.875% Ethyl Alcohol 53% Aluminum chlorhydrate 3.75% Aluminum chloride 4.5% Aluminum chlorhydroxide 23% Aluminum Chloride 3.6% Aluminum Chlorhydroxide 20.4% Aluminum Chlorhydrate 10% Aluminum Chlorhydrate 10% Aluminum Chlordrate 1.875% Ethyl Alcohol 53% Aluminum chlorhydrate 3.5% Aluminum chlorhydrate 2% Aluminum chlohydrate 2% Aluminum chlorhydroxide 22% Aluminum Chlorhydroxide 22%

Bristol-Myers Bristol-Myers

Bristol-Myers

Bristol-Myers Bristol-Myers

Dry Ban Antiperspirnt Deodorant Spray The Dry System Antiperspirant Cream The Dry System Antiperspirant Lotion Concentrate Mum Cream Deodorant Mum Roll-On Deodorant Mum Spray Deodorant

Bristol-Myers

Bristol-Myers Bristol-Myers Bristol-Myers

Bristol-Myers Bristol-Myers Bristol-Myers

Mum Powder Spray Antiperspirant Deodorant Softalc Deodorant Spray Powder Softalc Deodorant Spray Powder (Unscented) Trig Antiperspirant RollOn Deodorant

Bristol-Myers

Trig Antiperspirant RollOn Deodorant (Unscented)

Bristol-

140024-29

Bristol-Myers

Ultra Ban 5000 Antiperspirant Ultra Ban 5000 Antiperspirant (Unscented) Ultra Ban Powder Spray Arrid Extra Dry Antiperspirant Spray Arrid Extra Dry unscented Antiperspirant Spray Antiperspirant Spray (Experimental) Hour After hour Antiperspirant Right Guard Extra Strength Antiperspirant Secret 7 Sure Antiperspirants Additional Data 90-day subacute aerosol inhalation toxicity study Fresh Stick Additional Data Certain-dri Additional Data Additional Data Additional Data Arrid XX Antiperspirant Spray Additional Data on Arrid Extra Dry Additional Data on Arrid Roll-on Particle size measurements in aerosolized talc

Aluminum chlorhydrate 4.04% Aluminum Chloride 0.9% Aluminum chlorhydrate 4.04% Aluminum Chloride 0.9% Aluminum chlorhydrate 3.5% Aluminum chlorhydrate 3.5% Aluminum chlorhydrate 3.5% Aluminum Chlorohydrate 4% Zirconium chlorohydrate 1% Aluminum chlorhydrate 3% Aluminum Chlorohydrate Zirconium chlorohydrate Aluminum chlorhydrate, Zirconium oxychloride Aluminum glycinate Zirconium chlorohydrate, Aluminum chlorhydrate Glycine complex

Bristol-Myers

Bristol-Myers 140030-31 Carter Products Carter Products 140032 Carter Products

140033 140034 140035-36 140037-38 140039 140040 140041 140042-43 140044-45 140046 140047 140048 140049 140051 140052 140053

Carter Products Carter Products Gillette Proctor & Gamble Proctor & Gamble FDA Document Pennwalt Corp. Proctor & Gamble Leon Products, Inc. Proctor & Gamble Leon Products, Inc. Proctor & Gamble Carter Products Div., Carter-Wallace, Inc. Carter Products Carter Products Avon Products, Inc.

Sodium Aluminum chlorhydroxylactate Aluminum Chloride 13.3%

Zirconium-AluminumGlycine Complex Aluminum-Zirconium Chlorohydrate Complex

140053A

Wickhen Products, Inc.

Wickenol 303 Wickenol 321 Wickenol 323 Wickenol 324

Aluminum Chlorhydrate50% aqueous solution Aluminum Chlorhydrate crystals Aluminum Chlorhydrate Impalpaple powder Aluminum Chlorhydrate low-moisture impalpaple powder Sodium Aluminum Lactate powder Alcohol Soluble Aluminum Chlohydrate powder

Wickenol 340 Wickenol 363D 140054 140055 140056 140057 140058 The Cosmetic, Toiletry, & Fragrance Association, Inc. Lehn & Fink CTFA Person & Covey, Inc. Gillette Medical Evaluation Laboratories The Cosmetic, Toiletry and Fragrance Assn., Inc. Person & Covey, Inc. Additional information on “Antiperspirant Testing Protocol” Body All--Additional information Additional testing procedures Drysol Super Dri Soft and Dri and Right Guard Double Protection Roll-on Antiperspirant Information on ingredient nomenclature Drysol

Aluminum chloride 20% 20% Aluminum-zirconylhydroxychloride complex

140059 140060

Additional Data

140061

Carter Products Gillette Medical Evaluations Laboratories Sterling Drug, Inc. Revlon Research Center, Inc. Bristol-Myers Proucts The Proctor & Gamble Co. Reheis Chemical Company CTFA Armour-Dial, Inc. The Cosmetic, Toiletry and Fragrance Assn., Inc. Person and Covey, inc. CTFA

Nomenclature for ingredients “ “ “ “ ” ” ” ”

Nomenclature for ingredients and usage and dosage levels Nomenclature Information on water of hydration for ingredients Nomenclature Safety of talc Drysol Safety Protocol for aerosols REFERENCES (Alphabetical by Author) PANEL ADMINISTRATOR’S FILE VOLUME I Members C.V.’s Charge to Panel Summary Minutes Regulatory Analysis Assessment Statement of Exemption and Environmental Assessment Reports PANEL ADMINISTRATOR’S FILE VOLUME II Correspondence Additional data

140062 140063 140064 140065 THRU 140068

TFM VOLUME

1400PR

Has been established for Antiperspirant Drug Products

Public Administrative File OTC Vitamin and Mineral Drug Products (Docket No. 78N-0024)

VOLUME

SUBMITTED BY

TRADE NAME/SUBJECT

150001 150002 150003 150004 150005 150006 150007 150008 150009150010 150011 150012 150013 150014 150015 150016 150017 150018 150019 150020 150021 150022

Schering Corp. The Central Pharmacal Co. Marion Laboratories, Inc. Mallinckrodt Chemical Works Eastman Chemical Products, Inc. Ross laboratories International Pharmaceutical Corp. Smith Kline & French Laboratories Cooper laboratories, Inc. Merrell-National Laboratories Merrell-National Laboratories A.H. Robins Co. A.H. Robins Co. A.H. Robins Co. E.R. Squibb & Sons, Inc. E.R. Squibb & Sons, Inc. E.R. Squibb & Sons, Inc. E.R. Squibb & Sons, Inc. E.R. Squibb & Sons, Inc. E.R. Squibb & Sons, Inc. E.R. Squibb & Sons, Inc.

Mol-Iron Liquid Mol-Iron Tablets Mol-Iron Chronosule Tablets Niferex Tablets Niferex Elixir Niferex-150 Capsules Os-Cal tablets Toleron Suspension Toleron Tablets Vitamin E Proposed Products for Women on Oral Contraceptives Calcident Tablets Feosol Spansule Capsules Ferronord Tablets Vitron-C Hematinic Tablets Simron Plus Capsules Simron Capsules Allbee-T Mult-vitamins Adabee Multivitamins Adabe with Minerals Tables Allbee Capsules Allbee w/C Capsules Theragran Tablets Theragran Liquid Theragran-M Tablets Vitamin B-1 100mg Tablets Vitamin B-1 50mg Tablets Iron with Vitamin C Tablets Vitamin B-12 Capsules Niacin Tablets Vitamin A from Natural Sources Capsules Vitamin A Capsules B Complex with Vitamin C Capsules Stress Formula B Complex with Vitamin C Tablets Vitamin C Tablets Vitamin C Orange Flavored Tablets Vitamin C Tablets (Golden Bountry) Vitamin E Walnut Flavored Tablets Vitamin E Capsules Natural Vitamin E Capsules Crystalets Vitamin A Palmilets Stablets Vitamin A

150023

E.R. Squibb & Sons, Inc.

150024 150025 150026150027

E.R. Squibb & Sons, Inc. Pfizer Pharmaceuticals Hoffmann-LaRoche, Inc.

150028 150029 150030 150031 150032 150033150034 150035 150036 150037

Hoffmann-LaRoche, Inc. Hoffmann-LaRoache, Inc. Hoffmann-LaRoache, Inc. Hoffmann-LaRoache, Inc. Hoffmann-LaRoache, Inc. Hoffmann-LaRoache, Inc. Hoffmann-LaRoache, Inc. Hoffmann-LaRoache, Inc. Lederle Laboratories

Thiamine Riboflavin Niacin Vitamin B-6 Panthothenic Acid Ascorbic Acid Vitamin E Biotin Filibon Prenatal Capsules Filbon OT Prenatal Tablets Gevrabon Vitamin Mineral Supplement Gevral Capsules Gevral T Capsules Gevral Protein Gevrite Tablets Lederplex Capsules Lederplex Liquid Lederplex Tablets Stresscaps Stresstabs 600 Vi-Magna Capsules Ferro-Mandets Tablets Ferro-Sequels Capsules Incremin with Iron Syrup Peritinic Tablets Recoup Tablets Fermalox Tablets Fero-Gradumet Filmtab Fero-Grad-500 Filmtabs Iberet Filmtab Tablets Iberet Liquid Iberet-500 Filmtab Tablet Iberet -500 Liquid Iberol Filmtab Tablets Iberol-F Filmtab Tablets Daylong Tablets Optilets-500 Filmtab Tablets Optilets-M-500 Filmtab Tablets Surbex Filmtab Tablets Surbex w/C Filmtab Tablets Surbex-T Filmtab Tablets

150038 150039

William H. Rorer, Inc. Abbott Laboratories

150040

Abbott Laboratories

150041

ICI America Inc.

Ferancee Hematinic Tablets Ferancee-HP Hematinic Tablets Orexin Therapeutic Vitamin Supplement Tablets Probec Tablets Probec-T Tablets Theron Tablets Stuart Therapeutic Multivitamin Tablets Stuart Hematinic Liquid Stuart Hematinic Tablets Mucoplex Tablets Stuartinic Hematinic Tablets

150042

Plus Products

Plus Formula 10 Multimineral Tablets Plus Formula 14 Multi-mins Tablets Plus Formula 15 Multi-mins Tablets Plus Formula 22 Magnesium Oxide Powder Plus Formula 23 Manganese Tablets Plus Formula 49 Vitamin B Complex Tablets Plus Formula 49A Vitamin B Complex Tablets Plus Formula 50 Liver, Iron & B Vitamins Tablets Plus Formula 70 Vitamin B Complex Tablets with Vitamin C Plus Formaula 71 High Potency Vitamin B Complex with Vitamin C Tablets Plus Formula 72 Stress Supplement Tablets Plus Formula 74 Vitamin & Mineral Supplement Perles Plus Formula 75 B Complex 75 Tablets Plus Formula 77 Vitamin B Complex Syrup with Iron Plus Formula 78 Vitamin Syrup for Children Plus Formula 80A Bone Meal Powder Plus Formula 85 Natural Bone Meal with Magnesium, Manganese & Zinc Tablets Plus Formula 92 Granular Soya Lecithin Plus Formula 93A Lecithin Perles Plus Formula 100 DFS Perles Plus Formula 101A Vitamin A Perles Plus Formula 104A Emulsified A Perles Plus Formula 123 Paraaminobenzoic Acid (PABA) Tablets Plus Formula 125A Inositol Tablets Plus Formula 126 Inositol Powder Plus Formula 152 Emulsified Vitamin E Complex Perles Plus Formula 153 Vitamin E Complex Perles

150042 cont..........

Plus Formula 154A Emulsified Vitamin E Complex Perles Plus Formula 155 Vitamin E Complex Perles Plus Formula 156 Vitamin E Complex Perles Plus Formula 158 Vitamin E Tablets Plus Formula 159 Vitamin E Perles Plus Formula 162 Vitamin E Perles Plus Formula 163 Vitamin E Perles Plus Formula 164 Vitamin E Perles Plus Formula 165 Vitamine E Perles Plus Formula 175 Dietary Food Supplement Perles Plus Formula 180 Potassium & Iodine Tablets Plus Formula 184 Calcium and Magnesium Tablets Plus Formula 202A Vitamins A & D Perles Plus Formula 203A Vitamins A & D Tablets Plus Formula 205A Vitamins A,D, 7 E Perles Plus Formula 206 A, D & E Drops Plus Formula 207 Vitamins A & E Perles Plus Formula 222 High Potency Cod Liver Oil Plus Formula 234 Vitamin B-1 Tablets Plus Formula 242 Vitamin B-2 Tablets Plus Formula 249 Dried Yeast Tablets Plus Formula 250 Yeast Plus Plus Formula 251 Vitamin B-6 Tablets Plus Formula 252 Vitamin B-6 Tablets Plus Formula 253 Vitamin B-6 Tablets Plus Formula 260 Niacin Tablets Plus Formula 263 Niacinamide Tablets Plus Formula 264A Pantothenic Acid Tablets Plus Formula 265A Acerola Chews Tablets Plus Formula 266A Chewable Vitamin C Tablets

150042 cont....

Plus Formula 267A Chewable Vitamin C Tablets Plus Formula 273A Vitamin C Tablets Plus Formula 275 Vitamin C Complex Plus Formula 277 Vitamin C Complex Plus Formula 278 Vitamin C Powder Plus Formula 279 Vitamin C Powder Plus Formula 280A Vitamin C Tablets Plus Formula 282 Vitamin C Complex Tablets Plus Formula 290 Granular Kelp Plus Formula 304 Vitamin B-12 Tablets Plus Formula 333 Dried Yeast and Iron Tablets Plus Formula 380 Mint-A-Mins Chewable Vitamin Wafers Plus Formula 450 Instant Brewer’s Yeast Plus Formula 445 Iron Supplement Tablets Plus Formula 740 Tiger’s Milk Cookies Plus Formula 745 Tiger’s Milk Carob Coated Bar Plus Formula 746 Tiger’s Milk Real Peanut Butter Bar Plus Formula 747 Tiger’s Milk Peanut Butter & Honey Bar Plus Formula 748 Tiger’s milk Peanut Butter & Jelly Bar Plus Formula 749 Tiger’s Milk Calorie Watcher’s Snack Plus Formula 800 Tiger’s Milk Nutrition Booster Plain Plus Formula 825 Tiger’s Milk Nutrition Booster Natural Carob Flavor Plus Formula 850 Tiger’s Milk Nutrition Booster Vanilla Flavor Plus Formula 875 Nutrition Booster Natural Cocoa Flavor Plus Formula 86 Zinc 30mg Tablets Plus Formula 87 Zinc Tablets Plus Formula 98 Vita-Fems Tablets Plus Formula 122 PABA Tablets

150042 cont............

150043150047 150048 150049

The J.B. Williams Company, Inc. Ross Laboratories Signet Laboratories Incorporated

150050150052 150053 150054 150055 150056

McMurray & Pendergast (For Vitaminerals, Inc.) A.E. Staley Manufacturing Co. LaWall & Harrison Research Laboratories, Inc. LaWall & Harrison Research Laboratories, Inc. Mead Johnson Laboratories

Plus Formula 127 Choline Tablets Plus Formula 128 Inositol Tablets Plus Formula 157 Vitamin E Capsules Plus Formula 160 Vitamin E Capsules Plus Formula 166 Vitamin E Capsules Plus Formula 243 Vitamin B-2 Tablets Plus Formula 244 Vitamin B-2 Tablets Plus Formula 259 Pantothenic Acid Tablets Plus Formula 261 Niacin Tablets Plus formula 262 Niacinamide Tablets Plus Formula 303 Vitamin B-12 Tablets Geritol Liquid Geritol Tablets Alpha Tocopheryl Polyethylene Glycol 1000 Succinate B-12 Tablets Double Absorption B-12 Tablets Vitamin B-6 Tablets Vitamin B-1 Tablets Vitamin B-2 Tablets Double Absorption B-12 Tablets Anti-X Tablets pantothenic Acid Tablets Citrex Plus Tablets Toco E Sol Tablets Taste-E-Tab Power-B w/PABA Tablets Intensive Care B with C Tablets Premium Nutrition Plan Tablets Omni Nutrition Plan Tablets One Plan Multi-Vitamin-Mineral Supplement Tablets Ultra-Vite Multi-Vitamin-Mineral Supplement Tablets Neo-Tone Asimicaps Iron with Vitamins & Minerals Tablets Mag-Cal Balanced Super Citrex Tablets Bioflavanoids Inositol S.S.S. Tonic Tablets S.S.S. Tonic (Liquid) Feminins Tablets

150057

Sterling Drug Inc.

150058 150059 150060 150061 150062

Sterling Drug Inc. Sterling Drug Inc. Sterling Drug Inc. Sterling Drug Inc. Wm. T. Thompson Co.

Fergon Capsules Fergon w/C Caplets Fergon Compound Elixir Fergon Elixir Fergon Tablets Ironized Yeast Tablets Afaxin Capsules Betaxin Tablets Drisdol Pluravit Capsules Pluraxin Capsules Zinc Tablets Trace Elements Tablets Fluoride Tablets Multi-Minerals w/Sea Minerals Tablets Vitamin A Tablets Vitamin A & Vitamin D Capsules Vitamin D Tablets Vitamin E Tablets Vitamin E Capsules Vitamin E & C with A Capsules Vitamin K-1 Tablets Acerola C Chewable Tablets Vitamin C Tablets One Gram C Capsules C Ross Hips Tablets C-Flavoids “500" Tablets Rose Hips C-Flavoids “650" Tablets Flavoid Complex Tablets Ex-Po 36 Capsules (proposed) Ex-Po 36 Capsules Nuplex Tablets Iron Hematinic Tablets Neo-Globin Tablets Vitamin B-1 Tablets Vitamin B-2 Tablets Vitamin B-6 Tablets Vitamin B-12 Tablets B Complex Plus C Tablets B Complex “50" Tablets (proposed) B-Complex “50" Capsules B-Complex Capsules (proposed) Niacin Tablets NiacinamideTablets Pantothenic Acid Tablets Folic Acid Tablets

150063

Wm. T. Thompson Co.

150064

Wm. T. Thompson Co.

150065

Wm. T. Thompson Co.

150066

Wm. T. Thompson Co.

150067

Ayerst Laboratories

150068150069 150070150071 150072 150073

Vitaminerals, Inc. Vitaminerals, Inc. see 150126 The Council for Responsible Nutrition

Beminal 500 Tablets Beminal Forte with Vitamin C Capsules Beninal Vitamin B Complex with Iron and Liver Capsules Cytoferin Tablets Clusivol Chew Tablets Clusivet Tablets Clusivol Syrup Data and views on Vitamin D Data and views on Vitamin A

150074 150075 150076 150077 150078 150079

The Council for Responsible Nutrition The Council for Responsible Nutrition The Council for Responsible Nutrition The Council for Responsible Nutrition The Council for Responsible Nutrition Radiance Products Co.

Example labels of member companies. Safety and Efficacy review for Vitamins A, C, E, Niacin and fat soluable vitamin combinations-Data & Views Vitamin A reference bibliography. Ascorbic reference bibliography Reference bibliography for Vitamin E. Reference bibliography for Niacin and Niacinamide Reference bibliography for fatsoluble vitamins (A, E, D). Super Potency Multiple Vitamins & Minerals Tablets Norwegian Cod Liver Oil w/Vegetable Oils Capsules Vitamin B-6 Tablets Vitamin B-12 in a Special Base Tablets Super B-Complex Plus C Capsules Dry Aqua-E Tablets Bone Meal Plus Vitamin D and Iron Tablets Proportioned Magnesium Tablets Chewable Tasti C with Bioflavanoid Wafers Data and views on Iron indications, Use and Toxicity Neo-Calglucon Syrup Information on Magnesium. Information on lipotropic substances-discussion and summary. Information on vitamins, minerals and hematinic - discussion and summary Vitron-C Iron Therapy

150080150081 150082 150083150084 150085150087 150088 150089

Vitaminerals, Inc. Dorsey Laboratories Vitaminerals, Inc. Vitaminerals, Inc. Vitaminerals, Inc. Cooper Laboratories, Inc.

150090 150091 150091A 150092 150093 150094 150095 150096150104

General Mills Chemicals, Inc. R.L. Gaddy Co. TPR Pharmaceuticals, Inc. Cooper Laboratories, Inc. Ross Laboratories General Mills Chemicals, Inc. Abbott Laboratories Hoffman-LaRoche, Inc.

Vitamin E Vita-Pep Tablets B-Tinic Supplemental to a submission of ferrous fumarate-ascrbic acid bibliography Supplemental to volume 150048. Animal data on water soluble vitamin E. Material on Vitamin E Supplemental submission to volumes 150039-150040. Summary of the data on safety and efficacy of: Vitamin A, Thiamine, Riboflavin, Niacin, Vitamin B-6, Pantothenic Acid, Ascorbic Acid, Vitamin E, Biotin. Triamterene Supplemental submission on Theragran Tablets and Thergran-M Tablets. Absorption techniques and absorption data on vitamins in pharmaceutical products. Manufacturing overages of vitamins in pharaceutical products. Critical review of vitamin C -sodium ascorbate: Sodium warning recommended by the OTC VMH Panel. Critical review of OTC Panel addendum to Vitamin C review P. 5 under “B. Kidney or Bladder Stones”. Supplemental submission on data and views of vitamin E. Summary data on multi-vitamins Supplemental submission on “High Vitamin Dose Levels in Man”. Statement regarding safety of selfadministered iron preparations. Pertinent research articles Memorandum - 3 copies to this office submitted on behalf of the council for Responsible Nutrition Vitamin items Oyster shells, OS-CAL OS-CAL Tabs and Calcium carbonate

150105 150106 150107 150108 150109

Smith, Kline & French Laboratories E.R. Squibb & Sons, Inc. Hoffman-LaRoche, Inc. Hoffman-LaRoche, Inc. Hoffman-LaRoche, Inc.

150110

Hoffman-LaRoche, Inc.

150111 150112 150113 150114 150114A 150114B 150115 150116 150117 150118 150119

Eastman Chemical Products, Inc. Hoffman-LaRoache, Inc. Hoffman-LaRoache, Inc. Covington & Burling Linus Pauling Institute of Science & Medicine Wilmer, Cutler & Pickering Hoffman-LaRoche, Inc. Marion Laboratories, Inc. Marion Laboratories, Inc.

150120 150121 150122 150123 150123A 150123B 150124 150125 150126 150127 150128 150129 150130 150131 150132

Merrell-National Laboratories OTC Volume-collection of unpublished data Marion Laboratories, Inc. Hoffman-LaRoche, Inc. Hoffman-LaRoche, Inc. Hoffman-LaRoche, Inc. Hoffman-LaRoche, Inc. FDA Philadelphia Dry Yeast Co. The Proprietary Association ICI Americas, Inc. Marion Laboratories, Inc. FDA FDA FDA

Simron: Elem iron 10mg

OS-CAL tablets, calcium 250mg ergocalciferol (125 USP units) OTC Vitamin, and Hematinic Products (Vitamin A, B12, C, E, K, biotin) Biotin Vitamin E OTC Vitamin, Mineral, and Hematinic Products OTC Drug Literature Program Part I thru VI, October 15, 1973 Debittered Brewers Dry Yeast Draft Report Number 8 Calcium sulfate as a source of calcium Calcium carbonate, OS-CAL OTC Drug Literature Program Part I. Vitamins, General December 10, 1973 OTC Drug Literature Part II. Vitamins A,D,E OTC Drug Literature Program Part III. Pages 1-300 A. Cyanocobalamin B. Folic Acid C. Niacin D. Pantothenic Acid E. Pyridoxine HCL F. Riboflavin G. Thiamine HCL H. Vitamin B Complex OTC Drug Literature Program Part III. Pages 301-600 OTC Drug Literature Program Part III. Pages 601-865 OTC Drug Literature Program Part IV. Ascorbic Acid OTC Drug Literature Program Part V. Biotin, Choline, Inositol

150133 150134 150135 150136

FDA FDA FDA FDA

150137

FDA

150138 150139

FDA FDA

OTC Drug Literature Program Part VI. Hematinics, Minerals. A. Calcium Salts B. Copper Salts C. Iodine D. Iron Salts E. Magnesium Salts F. Phosphorus Salts G. Zinc Salts OTC Drug Literature Part I thru VI. January 11, 1974 Index of Submissions and Ingredients to VMH Panel (Breakdown of the volumes by product and Ingredients)

Volume 150140 150141 150142 150143 150144 150145 150146 150147 150148

Contents A Ba - B1 Bm - Bz Ca – Cn Co – Cz D E F G

150149 150150 150151 150152 150153 150154 150155 150156 150157 150158 150159 150160 150161 150162 150163 150164 150165 150166 150167 150168 150169 150PA1

H – Ha Hb – Hz I–J K L Ma – Mc Me – Mz N O P Ra – Ri Rj – Rz Sa – Sc Sd – Sl Sm – Sz T U–V W X–Z A–B C–Z Panel Administrator’s File (Correspondence File), Volume 1 Contents 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 Table of Contents Calls for Data List of Panel Members and Liaisons Curriculum Vitae for Panel Members General and Specific Charges Summary Minutes Interim Report List if Panel Submissions Regulatory Analysis Assessment Statement of Exemption and Environmental Assessment Reports

150PA2 150PA3 150PA4 150PA5 150PA6 150PA7

Panel Administrator’s File ( Correspondence File), Volume II (1972 – 1973) Panel Administrator’s File (Correspondence File), Volume III (1974) Panel Administrator’s File ( Correspondence File), Panel Administrator’s File (Correspondence File), Volume V (1976) Panel Administrator’s File (Correspondence File), Volume VI (1977) Panel Administrator’s File (Correspondence File), Volume VII (1978)

External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Drug Products for the Treatment of Diaper Rash Part I Docket No. 78N-0301 Index to OTC Volumes Volume No. 160021 160025 160027 160028 160038 160040 160041 Submitted By Pfizer Pharmaceuticals Corona Manufacturing Co. Warren-Teed Pharmaceuticals, Inc. The UpJohn Co. Miles Laboratories, Inc. Resinol Chemical Co. Macsil, Inc. Marketed Products/Subject Desitin Ointment Corona Ointment Taloin Diaper Rash Ointment Clocream Skin Cream Acid Mantle Crème, Acid Mantle Lotion Resinol Ointment, Resinol Greaseless Cream Balmex Ointment

160042 160053 A&B 160067 160069 160070 160077 160088 160091 160104 160204 160221 160236

Syntex Laboratories, Inc. Chesebrough-Pond’s, Inc. Block Drug Co., Inc. Cooper Laboratories, Inc. Cooper Laboratories, Inc. Bristol Myers Co. Macsil, Inc. Bristol Myers Co. USV Pharmaceutical Corp. USV Pharmaceutical Corp. Corona Manufacturing Co. Pennwalt Corp.

160242 through 160247

Sterling Drug Inc.

160271 160272 160277 160357 160362 160421 160427

Whitehall Laboratories, Inc. Whitehall Laboratories, Inc. American Home Products Corp. Stiefel Laboratories, Inc. University of Pennsylvania Macsil, Inc. Glenbrook Laboratories

Methakote Diaper Rash Crème Vaseline Pure Petroleum Jelly Tashan Super Skin Cream Aveeno Colloidal Oatmeal Aveeno Colloidal Oatmeal Ammens Powder Balmex Ointment Ammens Powder Pathoderm Cream, Panthoderm Lotion Panthoderm Cream Panthoderm Lotion Corona Ointment Caldesene Powder, Caldesene Ointment, Proposed Product Containing Calcium Undecylenate and Hydrocortisone Acetate Diaparene Ointment, Diaparene Peri Anal, Diaparene Baby Lotion, Diaparene Medicated Baby Powder, Diaparene Diaper Rinse Solution, Diaparene Diaper Rinse Tablets, Diaparene Diaper Rinse Granules Sperti Healing Ointment Sperti Healing Ointment Sperti Healing Ointment Zeasorb Super Absorbent Medicated Powder Corn Starch Study Balmex Ointment Cornstarch Study

External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Drug Products for the Prevention of Poison Ivy, Oak, and Sumac Part II Docket No. 78N-0301 Index to OTC Volumes Volume No 160074 160103 160132 160152 Submitted By Manidn Health and Safety, Inc. Unimed, Inc. Marion Health and Safety, Inc. Marion Health and Safety, Inc. Product Poison Ivy Wash Residerm (Poison Ivy Lotion) Zircreme, Ferric Chloride, Sting Kill Poison Ivy Wash

External Analgesic Drug Products for OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Drug Products for the Treatment of Fever Blisters Part III Docket No. 78N-0301 Index to OTC Volumes Volume No. 160008 160012 160013 160048 160096 160136 160177 160197 160213 160218 160231 Submitted By Commerce Drug Co., Inc. Commerce Drug Co., Inc. Commerce Drug Co., Inc. Campbell Laboratories, Inc. Blistex, Inc. Sterling Drug Inc. International Pharmaceutical Corp. Oral Prophylactic Assoc., Inc. Blistex, Inc. Glenbrook Laboratories Sterling Drug, Inc. Product Bio-Stik Tanac Tanac Stik Herpecin-L Blistex Ointment Campho-Phenique Gly-Oxide Liquid Mouth Komfort Blistik Lip Balm Campho-Phenique Campho-Phenique

External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record Published in the Federal Register on September 7, 1982 (47 FR 39412) Part III Statement on OTC Drug Products For the Treatment of Fever Blisters Docket No. 78N-0301 Panel Administrator’s File 06BPA8 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submission 1.6 Minutes of Panel Meetings 1.7 Correspondence 1.8 References

Administrative File Alcohol Products For Topical Antimicrobial OTC Human Use Docket No 75N-0183 Panel Administrator’s File 16JPA1 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence

Mercury-Containing Drug Products for Topical Antimicrobial OTC Human Use Index of OTC Volumes Docket No. 75N-0183 Volume 160025 160085 160154 160157 160160 160188 160189 160224 160235 160240 Submitted By Corona Manufacturig Co. Hynson, Westcott & Dunnig, Inc. Marion Health and Safety, Inc. Marion Health and Safety, Inc. Marion Health and Safety, Inc. Bowman Pharmaceuticals, Inc. Bowman Pharmaceuticals, Inc. Hynson, Westcott & Dunning, Inc. Corona Manufacturing Co. Eli Lilly and Co. Subject Parachlormercuriphenol Merbromin Merbromin Thimerosal Orthohydroxyphenyl mercuric chloride Ammoniated mercury Thimerosal Merbromin Merbromin Thimerosal

160270 160271 16HPA1-A 16HPA1-B

Hynson, Westcott & Dunnig, Inc. Whitehall Laboratories

Merbromin Phenylmercuric Nitrate Cited References Miscellaneous Uncited References

Administrative File OTC Mercury-Containing Drug Products for Topical Antimicrobial Use Docket No. 75N-0183 Panel Administrator’s File 16HPA1 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of panel Members nd Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence

Alcohol Drug Products for Topical Antimicrobial OTC Human Use Index to OTC Volumes (Docket No. 75N-0183) Volume No. 160045 160084 160107 160148 160155 Submitted By Parke, Davis & Company Sea Breeze Laboratories, Inc. Cramer Products, Inc. Marion Health and Safety, Inc. Marion Health and Safety, Products/Subject Lavacol Sea Breeze Fung-O-Spray Isopropanol Sepps 70/10 Isopropanol 70 percent

160173 160184 160185 160206 160207 160209 160249 160250 160251 160278 160377 160382 16JPA1-A 16JPA1-B

Inc. Holland Rantos Company, Inc. Bowman Pharmaceuticals, Inc. Bowman Pharmaceuticals, Inc. Holland Rantos Company, Inc. Eli Lilly and Company Eli Lilly and Company Cramer Products, Inc. Cramer Products, Inc. Cramer Products, Inc. Whitehall Laboratories, Inc. Vestal Laboratories Vestal Laboratories

Steri Wipe Alcohol Swabs Isopropyl alcohol 70 percent Isopropyl alcohol 91 percent Ethylene Oxide in 70 percent Isopropyl alcohol Isopropyl alcohol 91 percent Isopropyl alcohol 91 percent Nitrotan Nitrotan (Aerosol) Iso-Quin Anbesol Alcare Alcare Cited References Uncited References

Public Administrative File OTC Skin Bleaching Products

Volume 160056

Company USV Pharmaceutical Corporation Tuckahoe, New York 10707

Product Esoterica Regular, Esoterica Facial, Esoterica Fortified, Esoterica Lotion, Esoterica Special, Golden Peacock

160072 160081

Plough, Inc. Memphis, Tenn. 38151 Chattem Drug & Chemical Co. Chattanooga, Tenn. 37409 Nicholas Products Ltd. Waukeska, Wisconsin 53186 Ambi Cosmetics – USA (Animal Safety Data, Part 1) Ambi Cosmetics – USA (Animal Safety Data, Part 2) Ambi Cosmetics – USA (Medical rationale) Ambi Cosmetics – USA (Effectiveness data) Ambi Cosmetics – USA (Human safety data) Skin Bleaching Products— References

Bleach Cream Artra Skin Tone Cream Ultra Nadinola Cream, Deluxe Nadinola Complexion Cream, Derma Blanch, Nadinola Double Care Lotion Ambi Skin Cream (Vol. I) Hydroquinone (Vol. II) Hydroquinone (Vol. III) Ambi skin cream (Vol. VI) Hydroquinone and Glyceryl – PABA (Vol. V) Hydroquinone and Glyceryl – PABA (Vol. IV)

160112 160113 160114 160115 160116 160117 16A294

Panel Administrator’s File

16APAI—Panel Administrator’s File Volume I—Skin Bleaching Products

1. 2. 3. 4. 5. 6. 7.

Federal Register call for data List of Panel members and curricula vitae General charge to OTC Drug Products Review Panels Statement of Exemption and Environmental Assessment Report Economic Impact Assessment Statement Minutes of the Miscellaneous External OTC Drug Products Review Panel Correspondence to the FDA staff or Panel on these drug – None.

There is no Panel Administrator’s File Volume II

Nailbiting and Thumbsucking Deterrent Drug Products Panel Index Volume 160010 Submitted By Commerce Drug Co., inc. Subject Sucrose Octaacetate Isopropyl Alcohol

160020 160054 160168 160172 160228 160295 (2 Volumes)

The Mentholatum Co., Inc. Purepac Pharmaceutical Co. Parke Davis & Co. Parke Davis & Co. Parke Davis & Co. International Research and Development Corporation

Sucrose Octaacetate Denatonium Benzoate Denatonium Benzoate Sucrose Octaacetate Denatonium Benzoate Denatonium Benzoate Denatonium Benzoate

Nailbiting and Thumbsucking Deterrent Drug Products Panel Index

Volume 160416 160417

Subject Cited References Miscellaneous Uncited References

Administrative File OTC Nailbiting and Thumbsucking Deterrent Drug Products Docket No. 80N-0146

Panel Administrator’s File

Volume 16DPA1

Contents Panel Administrator’s File 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File

Camphorated Oil and Camphor-Containing Products Panel Index

Volume 160291 160383

Submitted By American Pharmaceutical Association Carmine Varane, Pharmacist

Subject Camphorated Oil Camphorated Oil

PANEL SUBMISSIONS ON OTC MISCELLANEOUS EXTERNAL DRUGS PRODUCTS CONCERNING OTC DRUG PRODUCTS CONTAINING CAMPHOR REGARDING RE-OPENING OF RECORD OF RECORD FOR EXTERNAL ANALGESIC 78N-0301; ANORECTAL DRUG PRODUCTS 80N-0050; AND COUGHCOLD 76N-0052

Volume 160222 160358

Submitted By University of Nebraska Medical Center Carol R. Angle, MD University of Pennsylvania Hospital Harry E. Morton, ScD

Subject Camphor Camphor

Administrative File OTC Camphorated Oil and Camphor-Containing Drug Products Dockets No 80N-0227

Volume 16BPA1

Contents 1.0 References 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 Index to Panel Submissions 1.5 Regulatory Analysis Assessment 1.6 Summary Minutes of Panel Meetings 1.7 Correspondence File

Miscellaneous External Advisory Review Panel Index For OTC Wart Remover Drug Products Submissions

Volume 160004 160007 160282 160283

Submitted By Whitehall Laboratories, Inc. Commerce Drug Co., Inc. Whitehall Laboratories, Inc. Whitehall Laboratories, Inc.

160287 160289 160359 160376 160411 160412

Daywell Laboratories Corp. Stiefel Laboratories, Inc. Stiefel Research Institute, Inc. Dr. Mary H. Bunney Royal Infirmary Edinburgh, Scotland, UK

Subject Compound W B-D-B Wart Remover Literature References Supplemental Data—Studies Pertaining to Salicylic Acid, Glacial Acetic Acid, Acetone Collodion,and Collodion Vergo Duofilm Duofilm-C Supplemental Data—Studies Using Salicylic Acid and Lactic Acid Cited References Miscellaneous Uncited References

Administrative File

Wart Remover Drug Products for Over-the-Counter Human Use Docket No. 80N-0238

Panel Administrator’s File

Volume 16CPA1

Contents Panel Administrator’s File 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File

Ingrown Toenail Relief Drug Products Panel Index

Volume 160100 160127 160280 160384 160386 160419 160420

Submitted By Scholl, Inc. Whitehall Laboratories Scholl, Inc. Whitehall Laboratories Scholl, Inc.

Subject Sodium Sulfide Chlorobutanol, Tannic Acid, Isopropyl Alcohol Sodium Sulfide Chlorobutanol, Tannic Acid, Isopropyl Alcohol Sodium Sulfide Cited References Miscellaneous Uncited References

Administrative File OTC Ingrown Toenail Relief Drug Products Docket No. 80N-0348

Panel Administrator’s File

Volume 16EPA1

Contents Panel Administrator’s File

1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File

Hair Grower and Hair Loss Prevention Drug Products Panel Index

Volume 160118 160232 160425 160426

Submitted By Edwards Industrial Center, Inc. Shepard D. Roberts

Subject Tetracaline Hydrochloride, Benzoic Acid, Ascorbic Acid Lanolin, Wheat Germ Oil, Coconut Oil, Vegetable Olive Oil Cited References Miscellaneous Uncited References

Administrative File OTC Hair Grower and Hair Loss Prevention Drug Products Docket No. 80N-0357 Panel Administrator’s File

Volume 16FPA1

Contents Panel Administrator’s File 1.1 Call for Data 1.2 List of panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File

Corn and Callus Remover Drug Products Index to OTC Volumes

Volume No. 160003 160073 160079 160097

Submitted By Whitehall laboratories Chattem Drug & Chemical Co. E.G. Behren Scholl, Inc.

Products/Subject Freezone Blis-To-Sol Corn Callus Remover “2” Drop Corn/Callous Remover, Callous Salve, Corn Salve, Halluxol, Onixol and Corn and Callous Products Same as 160097 Same as 160097 Same as 160097 Same as 160097 Freezone A report on “Outpatient Utilization of ICPM Foot Clinic” Salicylic acid Zinc chloride, salicylic acid, and acetic acid Salicylic acid Blue Jay Corn Plasters 40 percent salicylic acid disks Phenoxyacetic acid Salicylic acid Phenoxyacetic acid Cited References Uncited References

160098 160099 160100 160101 160133 160256 160282A & B 160283 160285 160292 160293 160294 160380 160398 16IPA1-A 16IPA1-B

Scholl, Inc. Scholl, Inc. Scholl, Inc. Scholl, Inc. Whitehall Laboratories Scholl, Inc. Whitehall Laboratories Whitehall Laboratories Scholl, Inc. Combe, Inc. Scholl, Inc. Combe, Inc. Scholl, Inc. Combe, Inc.

Administrative File OTC Corn and Callus Remover Drug Products Docket No. 81N-0122 Panel Administrator’s File

Volume 16IPA1

Contents 1.1 Call to Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence

Topically Applied Hormone-Containing Drug Products Index of OYC Volumes (Docket No. 81N-0144)

Volume No. 160055

Submitted By Sterling Drug, Inc. New York, NY 10016

160057

USV Pharmaceutical Corporation Tuckahoe, NY 10707 Helena Rubinstein New York, NY 10022

160095

160195

FDA, Bureau of Drugs Office of Compliance

16GPA1-A

Products/Subject Satura Moisture Cream with Hormones; Satura Moisture Lotion with Hormones; Moisturing Hormone Hand Cream; Cellogen Moisturing Hormone Cream with Protein Hydrolysate Hormonex Beauty Serum; Hormonex in Cream; Hormonex hair and Scalp Serum Ultra Feminine Cream with Natural Estrogen and Progesterone; Ultra Feminine beauty Oil with Natural Estrogen and Progesterone Information to the Panel regarding potential hazard of topical skin and hair preparations containing various hormones. Cited References

Administrative File Topically Applied Hormone-Containing Drug Products For Over-The-Counter Human Use (Docket No. 81N-0144) Panel Administrator’s File Volume 16GPA1 Contents 1.1 Call for Data 1.2 List of panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence

Pediculicide Drug Products for OTC Human Use Index of OTC Volumes (Docket No. 81N-0201) Volume No 160011 160046 160075 160092 160094 160130 160137 160138 160163 160202 160217 160220 160227 160264 160279 160360 160400 160403 16KPAI-A 16KPAI-B Submitted By Commerce Drug Company, Inc. Norcliff laboratories, Inc. Block Drug Company, Inc. McKesson laboratories Norcliff Laboratories, Inc. FMC Corporation Pfizer Pharmaceuticals, Inc. Pfizer Pharmaceuticals, Inc. Pfizer Pharmaceuticals, Inc. Norcliff Thayer, Inc. Block Drug Company, Inc. Block Drug Company, Inc. Pfizer Pharmaceuticals, Inc. Fairfield american Corporation Pfizer Pharmaceuticals, Inc. Pfizer Pharmaceuticals, Inc. Norcliff Thayer, Inc. Laboratories Applipharm SA Products/Subject BARC Cream and Liquid A-200 Pyrinate Liquid and Gel Dolex Gel and Foaming Liquid A-200 Pyrinate Liquid and Gel Kerosene Efficacy data on piperonyl butoxide—pediculosis control. RID RID RID A-200 Pyrinate Liquid and Gel Dolex Dolex RID A-pyrenone—pediculosis control RID RID A-200 Pyrinate Liquid and Gel PARA-2 Cited References Uncited References

Administrative File Pediculicide Drug Products For OTC Human Use Docket No. 81N-0201

Panel Administrator’s File

Volume 16KPAI

Contents 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence

Boil Ointment Drug Products for OTC Human Use

Index to OTC Volumes (Docket No. 82N-0054)

Volume No 160005 160182 160214 16LPA1-A

Submitted By Commerce Drug, Co., Inc. Bowman Pharmaceuticals, Inc. Press Chemical and Pharmaceutical Laboratories, Inc.

Products/Subject Boil-Ease Bowman Drawing Paste Epsal Ointment Cited References

Administrative File Boil Ointment Drug Products for OTC Human Use Docket No 82N-0054

Volume 16LPA1

Contents 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence

External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Drug Products for the Treatment of Diaper Rash Part I Docket No. 78N-0301 Index to OTC Volumes

Volume No 160021 160025 160027 160028 160038 160040 160041 160042 160053 160067 160069 160070 160077 160088 160091 160104

Submitted by Pfizer Pharmaceuticals Corona Manufacturing Co. Warren-Teed Pharmaceuticals, Inc. The UpJohn Co. Milies Laboratories, inc. Resinol Chemical Co. Macsil, Inc. Syntex laboratories, Inc. Chesebrough-Pond’s, Inc. Block Drug Co. Ic. Cooper Laboratories, Inc. Cooper Laboratories, Inc. Bristol Myers Co. Macsil, Inc. Bristol Myers Co. USV Pharmaceutical Corp.

Marketed Products/Subject Desitin Ointment Corona Ointment Taloin Diaper Rash Ointment Clocream Skin Cream Acid Mantle Cream, Acid mantle Lotion Resinol Ointment, Resinol Greaseless Cream Balmax Ointment Methakote Diaper Rash Crème Vaseline Pure Petroleum Jelly Tashan Super Skin Cream Aveeno Colloidal Oatmeal Aveeno Colloidal Oatmeal Ammens Powder Balmax Powder Ammens Powder Panthoderm Cream, Panthoderm Lotion

160204 160221 160236

USV Pharmaceutical Corp. Corona manufacturing Co. Pennwalt Corp.

160242 through 160247

Sterling Drug Inc.

160271 160272 160277 160357 160362 160421 160427

Whitehall Laboratories, inc. Whitehall Laboratories, Inc. American Home Products Corp. Stiefel Laboratories, Inc. University of Pennsylvania Macsil, Inc. Glenbrook laboratories

Panthoderm Cream Panthoderm Lotion Corona Ointment Caldesene powder, Caldesene Ointment, Proposed Product Containing Calcium Undecylenate and Hydrocortisone Acetate Diaparene ointment, Diaparene peri Anal, Diaparene Baby Lotion, Diaparene Medicated Baby Powder, Diaparene Diaper rinse Solution, Diaparene Diaper Rinse Tablets, Diaparene Diaper Rinse Granules Sperti Healing Ointment Sperti Healing Ointment Sperti Healing Ointment Zeasorb Super Absorbent Medicated Powder Corn Starch Study Balmax Ointment Cornstarch Study

Administrative File External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record Published in the FEDERAL REGISTER on September 7, 1982 (47 FR 39412) Part I Statement on OTC Drug Products For the Treatment of Diaper Rash Docket No. 78N-0301 Panel Administrator’s File

Volume 06BPA6

Contents 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions

1.6 Minutes of Panel Meetings 1.7 Correspondence 1.8 Cited References 1.9 Uncited References

External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Drug Products for the Prevention of Poison Ivy, Oak, and Sumac Part III Docket No. 78N-0301 Index to OTC Volumes

Volume No. 160103 160132 160152

Submitted By Unimed, Inc. Marion Health and Safety, Inc. Marion Health and Safety, Inc.

Product Residerm (Poison Ivy Lotion) Zircreme,. Ferric Chloride, Sting-Kill Poison Ivy Wash

External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Male Genital Desensitizing Drug products Part IV Docket No. 78N-0301 Index to OTC Volumes

Volume 160001 160014 160171 160260 160266 160281 160290 160388 06BPA9-A 06BPA9-B

Sumitted By Frederick Damrau, MD Commerce Drug Co., Inc. Ciba-Geigy Corp. Keller and Heckman for Pound International Corp. Keller and Heckman for Pound International Corp. Del Laboratories Commerce Drug Co., Inc. Del Laboratories

Product Culminal Detane Nupercainal Ointment Stud-100 Stud-100 Detane Detane Detane Cited References Uncited References

Administrative File External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record Published in the FEDERAL REGISTER on September 7, 1982 (47 FR 39412) Part IV Statement on OTC Male Genital Desensitizing Drug Products Docket No. 78N-0301 Panel Administrator’s File

Volume 06BPA9

Contents 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions

1.6 Minutes of Panel Meetings 1.7 Correspondence

External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Astringent Drug Products Part V Docket No. 78N-0301 Index to OTC Volumes Volume No. 160022 160038 160039 160069 Submitted By Marion Laboratories Inc. Dome Laboratories Dome Laboratories Cooper Laboratories, Inc. Marketed Products/Subject Bluboro Powder Acid Mantle, Crème, Lotion Domeboro Tablets, Powder Acnaveen Bar, Cream, Aveeno Bar, bath, Oilated Bath, Avenol Bath Additive, BurVeen Wet Dressing Powder, Emulave bar, Nixoderm Ointment, Packers Pine Tar Shampoo, Soap, Sebaveen Shampoo Acnaveen bar, Cream, Aveeno Bar, bath, Oilated bath, Avenol bath Additive, Bur Veen Wet Dressing Powder, Emulave bar, Nixoderm Ointment, Packers

160070

Cooper Laboratories, Inc.

160093 160140 160219 160230 160233 160354 160396 160409 160413 160428 160429 160433 160435 06BPA10-A 06BPA10-B

R.L. Gaddy Co. Marion Laboratories, Inc. Marion Laboratories, Inc. Marion Laboratories, Inc. Cox Drugs Humpheys Pharmacel, Inc. Stiefel Research Institute, Inc. Perito, Duerk, Carlson & Pinco for Requa Manufacturing Co., Inc. The Woltra Company, Inc. The E. E. Dickinson Co. Beecham Products American Distilling and Manufacturig Co., Inc. Requa manufacturing Co., Inc.

Pine Tar Shampoo, Soap, Sebaveen Shampoo Ez-It Medicated Foot Powder Bluboro Powder Bluboro Powder Bluboro Powder Formula “U” Witch Hazel AluWets Aluminum Sulfate Styptic Pencil Aluminum Sulfate Styptic Pencil Witch Hazel OTC Astringent Vaginal Douche Drug Products Witch Hazel Study Aluminum Sulfate Cited References Uncited References

Administrative File External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record Published in the FEDERAL REGISTER on September 7, 1982 (47 FR 39412) Part V Statement on OTC Astringent Drug Products Docket No. 78N-0301 Panel Administrator’s File

Volume 06BPA10

Contents 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence

External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record; OTC Insect Bite Neutralizer Drug Products Part VI Docket No. 78N-0301 Index to OTC Volumes

Volume No. 160074 160119 160159

Submitted By Marion Health and Safety, Inc. Tender Corp. Marion Health and Safety,

Product Sting Kill Swabs After Bite Sting Kill Swabs

160434

Inc. Tender Corp.

After Bite

Administrative File External Analgesic Drug Products For OTC Human Use; Establishment of a Monograph and Reopening of Administrative Record Published in the FEDERAL REGISTER on September 7, 1982 (47 FR 39412) Part VI Statement on OTC Insect Bite Neutralizer Drug Products Docket No. 78N-0301

Panel Administrator’s File

Volume 06BPA11

Contents 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence 1.8 References

OTC Drug Products for the Control of Dandruff Saborrheic Dermatitis, and Psoriasis; Establishment of Monograph Docket No. 82N-0214 Index to OTC Volumes

Volume No. 160033 160042 160043 160047

Submitted By Denver Chemical Mfg. Co. Syntex Laboratories, Inc. Reed and Carnrick Reed and Carnrick

Marketed Products/Subject Siroil Methakote Tarbonis Alphosyl

160050 160051 160059 160060 160068 160069

Reed and Carnrick Westwood Pharmaceuticals, Inc. Purex Corp., Ltd Purex Corp., Ltd Block Drug Co., Inc. Cooper Laboratories, Inc.

Sebical Anti-dandruff Shampoo Balnetar Cuticura medicated Liquid Cuticura Medicated Ointment Terin Cream, Tegrin Foam, Tegrin Medicated Soap Acnaveen Cream, Packer’s Pine Tar Liquid Shampoo, Packer’s Pine Tar Soap, Sebaveen Supplemental data Supplemental data Oxipor VHC Lotion Denorex Medicated Gel Shampoo, Denorex Medicated Liquid Shampoo Baker’s P & S Liquid, Baker’s P & S Ointment Mazon Medicated Cream Mazon Medicated Soap Oxipor VHC Lotion Estar Therapeutic Tar Gel Hospital Brand Psoriasis Emulsion Letter of Communication on coal tar Listerine Antiseptic Listerine Anitseptic Coal tar Products Dermakon Dandruff Shampoo Meted Cream Shampoo, Meted Lotion Shampoo Dial Conditioning Dandruff Shampoo for Normal Hair, Dial Conditioning Shampoo for Dry hair, Dial Conditioning Shamposs for Oily Hair References References References Head and Shoulders Mitchum Dandruff Shampoo Sebb Lotion Mazon Medicated Shampoo Glover’s Imperial Scarcoptic Mange Medicine Glover’s Imperial Medicated

160070 160087 160129 160134 160201 160237 160238 160241 160253 160255 160267 160275 160276 160286 160297 160298/ 160299 160300

Cooper Laboratories, Inc. Westwood Pharmaceuticals, Inc. Whitehall Laboratories Whitehall Laboratories Chester A. Baker Laboratories, Inc. Mitchum-Thayer, Inc. Mitchum-Thayer, Inc. Whitehall Laboratories Westwoord Pharmaceuticals, Inc. H.B. Distributing Co. Dr. Zackman Warner Lambert Co. Warner Lambert Co. The Proprietary Association Preston Pharmaceuticals, Inc. Texas Pharmacal Co. Armour-Dial, Inc.

160301 160302 160303 160304 160305 160306 160307 160308 160309

Armour-Dial, Inc. Armour-Dial, Inc. Armour-Dial, Inc. Procter and Gamble Mitchum-Thayer, Inc. Max Factor Mitchum-Thayer, Inc. H. Clay Glover Co., Inc. H. Clay Glover Co., Inc.

160310 160311 160312 160313 160314 160315 160316 160317 160318 160319 160320 160321 160322 160323 160324 160325 160326 160327 160328 160329 160330 160331 160332

H. Clay Glover Co., Inc. Marion Laboratories, Inc. Olin Corp. Flow Pharmaceuticals Alcon Laboratories, Inc. Whitehall Laboratories G.S. Herbert Laboratories Hess Hair Milk Laboratories, Inc. Texas Pharmacal Co. Sterling Drug, Inc. Sterling Drug, Inc. Sterling Drug, Inc. Sterling Drug, Inc. Westwood Pharmaceuticals, Inc. Westwood pharmaceuticals, Inc. Westwood Pharmaceuticals, Inc. R. Schattner Co., Pharmaceuticals Smith, Kline, and French Laboratories H. Clay Glover Co., Inc. H. Clay Glover Co., Inc. H. Clay Glover Co., inc. Purdue Frederick Co. Colgate-Palmolive

Soap Glover’s Imperial Medicated Ointment Metasep Medicated Shampoo Zinc Omadine Nu-Flow Ionil, Ionil-T Denorex Medicated Liquid Shampoo Vanseb Dandruff Shampoo, Vanseb-T Tar Shampoo Hess Hair Milk Meted-2 Cream Shampoo, Meted-2 Lotion Shampoo Cradol Methylbenzethonium chloride Double Danderine Phisoden Sebulex Conditioning Shampoo Foxtex Cream Sebutone AntiSEBORRHEIC Tar Shampoo Chloraderm Pragmatar Supplemental data Glover’s Imperial Medicated Soap Supplemental data Glover’s Imperial Medicated Ointment Supplemental data Glover’s Imperial Sarooptic Mange Medicine Betadine Shampoo Grenadier Dandruff Control hair Groom, Wildroot Dandruff Treatment hair Groom Look Twice Anti-dandruff Shampoo Look Twice Anti-dandruff Shampoo Safety and efficacy of zinc pyrithione Supplemental data Supplemental data Supplemental data Glover’s Imperial Medicated Soap

160333 160334 160335 160336 160337 160338

Colgate-Palmolive Colgate-Palmolive Colgate-Palmolive Colgate-Palmolive Colgate-Palmolive H. Clay Glover Co., Inc.

160339 160340 160341 160342 160343 160344 160345 160346 160347 160348 160349 160350 160351 160352 160353 160355 160356 160363 160364 160365 160366 160367 160368 160369 160370 160371 160372 160373 160374 160375 160378 160379 160381 160385 160387 160389 160390

Block Drug Co., Inc. Helene Curtis Industries, Inc. American Cyanamid Co. Penwalt Corp. Hask, Inc., Toiletries Hask, Inc. Toiletries h. Clay Glover Co., Inc. Gillette Medical Evaluation Laboratories Texas Pharmacal Co. Texas Pharmacal Co. Gillette Co. R.T. Vanderbilt Co., inc. Helene Curtis Industries, Inc. Alberto-Culver Co. Warner-Lambert Co. US Borax Research Westwood Pharmaceuticals, Inc. Abbott Laboratories Stiefel laboratories, Inc. Block Drug Co., inc. Olin Corp. Olin Corp. Olin Corp. Procter & Gamble Procter and Gamble Procter and Gamble Procter and Gamble Procter and Gamble Procter and Gamble Westwood Pharmaceuticals, Inc. Avon Products, Inc. Mitchum-Thayer, Inc. The Proprietary Association Abbott Laboratories Block Drug Co., inc. Procter and Gamble National Cancer Institute

Tegrin Medicated Shampoo Enden Lotion Shampoo Bibliography of omadines Hydrocortisone acetate and calcium undecylenate Hask D.S.T. Treatment Shampoo Hask Hair and Scalp Treatment Rewocid SBU 185 Safety and efficacy of zinc omadine Pentrax Tar Shampoo Supplemental data Selenium sulfide Vancide 89 RE Suave Dandruff Shampoo Rinse Away Dandruff Rinse Listerine Antiseptic Toxicity of Boric acid and sodium tetraborate Sebulex Conditioning Shampoo Selsun Blue for Normal Hair, Selsun Blue for Dry Hair, Selsun Blue for Oily Hair Polytar Shampoo Hydrocortisone alcohol and coal tar extract Toxicological summary of zinc omadine Bibliography I Bibliography II Safety and efficacy of zinc pyrithione References 1-25 References 26-50 References 51-75 References 76-100 References 101-121 Supplemental data Estar Gel Keep Clear Anti-dandruff Shampoo Mazon Medicated Cream Coal tar Products Safety and evaluation o selenium sulfide Tegrin Shampoo Supplemental data Head and Shoulders Bioassay of Selsun for Possible Carcinogenicity

160392 160393 160394 160395 160397 160401 160402 160404 160405 160406 160407 160408 160410 160414 160418 160430 160431 160432 160436

Beecham Products, Inc. R.T. Vanderbilt Co., inc. Emery Uncommon Chemicals Purdue Frederick Co. Westwood Pharmaceuticals, Inc. Helene Curtis Industries, inc. Emery uncommo Chemicals Plough, Inc. Helene Curtis Industries, Inc. Neutrogena Corp. Stiefel Laboratories, Inc. H.B. Distributing Co. Hask, Inc., Toiletries Westwood Pharmaceuticals, inc. The proprietary Assocaition Whitehall Laboratories The Proprietary Association National Psoriasis Foundation Dr. R.B. D’Agostino

Zinc pyrithione anti-dandruff hairgroom Supplemental data Vancid 89 RE Undeclenic acid monoethanolamide sulfosuccinate, sodium salt Supplemental data Betadine Shampoo Sebucare Scalp Lotion, Supplemental data Supplemental data Enden lotion Shampoo Ogilvie Dandruff Shampoo Sulfur-8 Hair and Scalp Conditioner Validation of the IBT Study Suave Dandruff Shampoo T-Gel Shampoo Polytar Bath Hospital Brand Psoriasis Emulsion Letter of communication Supplemental data Coal Coal Coal Coal tar project tar lotions tar project tar

Statistical evaluation

Administrative File OTC Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis Establishment of a Monograph Published in the FEDERAL REGISTER of December 3, 1982 (47 FR 54646)

Docket No. 82N-0214 Panel Administrator’s File Volume 16MPA1 Contents 1.1 Call for Data 1.2 List of panel Members and Liaisons 1.3 Curriculum Vitae of panel Member and liaisons 1.4 General Charge to Panel 1.5 Index to Panel Submissions 1.6 Minutes of Panel Meetings 1.7 Correspondence 1.8 Cited References 1.9 Uncited References

16MPA1-A 16MPA1-B

NO_______TFM_____________ VOLUME WAS MADE FOR__Naibiting and____________________ __thumbsucking Deterrent Drug_Products _________________________________________________

NO_____TFM_____________ VOLUME WAS MADE FOR____Wart Remover________________ _Drug Products _________________________________________________________________

TFM VOLUME____16ATFM________________________________ Has been established for__Skin Bleaching Drug Products___________________________________

TFM VOLUME______16BTFM_____________________ Has been established for__Hair Grower and hair Loss Prevention Drug Products________

TFM VOLUME____16ETFM_______________________ Has been established for____Ingrown Toenail Drug Products_______________________________________

FR VOLUME__16BFR____________________ Has been established for____Camphorated Oil Drug Products_____________________________

STOMACH ACIDIFIER ADMINISTRATIVE RECORD (Docket No. 79N-0176)

Index to Panel Submissions

Volume No. 170011 170023 170049 170103 170104 170105 170124

Firm Stuart Pharmaceuticals Winthrop Laboratories Dorsey laboratories Eli Lilly and Company Eli Lilly and Company Stuart Pharmaceuticals Eli Lilly and Company

Subject Stuart Amino Acids with B12 Acidol-Pepsin Kanulase Tablets Acidulin (glutamic acid hydrochloride) Volume I Acidulin (glutamic acid hydrochloride) Volume II Normacid Supplements Acidulin (glutamic acid hydrochloride)

SWEET SPIRITS OF NITRE FOR OVER-THE-COUNTER HUMAN USE ADMINISTRATIVE RECORD (Docket No. 79N-0177)

INDEX TO PANEL SUBMISSION

Volume No. 170163

Contents 1. Letter dated August 30, 1976, to Robert J. Haggerty, M.D., from Joseph P. Hile, Acting Commissioner of Food and Drugs, pertaining to sweet spirits of nitre. 2. TWX: Injury/Death Investigation, Sweet Spirits of Nitre, Complaint Form # X041235, dated November 20, 1974. 3. TWX: Death investigation, Sweet Spirits of Nitre, dated November 22, 1974. References Panel Administrator’s File

170183 170PA1

CHOLECYSTOKINETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ADMINISTRATIVE RECORD (Docket No. 79N-0368)

INDEX TO PANEL SUBMISSIONS Volume No. 170045 170184 17CPAI Submitted by Gray Pharmaceutical Co. Subject G.B.-Prep Emulsion (Corn oil) References Panel Administrator’s File

ANTHELMINTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ADMINISTRATIVE RECORD (Docket No. 79N-0378)

Volume No. 170024 170033 170068 170069 170070 170071 170072 170073 170101 170122 170133 170134 170158 170160

Submitted By Sterling Drug Company Pfizer Pharmaceuticals Inc. Pfizer Pharmaceuticals Inc. Pfizer Pharmaceutical Inc. Pfizer Pharmaceuticals Inc. Pfizer Pharmaceuticals, Inc Pfizer Pharmaceuticals, Inc. Pfizer Pharmaceuticals, Inc. Scientific Associates inc. Pfizer Pharmaceuticals Inc. Sterling Drug Co. Pfizer Pharmaceuticals Inc. Pfizer Pharmaceuticals Inc. Pfizer Pharmaceuticals Inc.

Subject Jayne’s PW Vermifuge Antiminth Oral Suspension Pyrantel Pamoate oral Suspension (Vol. 1 of 6) Pyrantel Pamoate Oral Suspension (Vol. 2 of 6) Pyrantel Pamoate Oral Suspension (Vol. 3 of 6) Pyrantel Pamoate Oral Suspension (Vol. 4 of 6) Pyrantel Pamoate Oral Suspension (Vol. 5 of 6) Pyrantel Pamoate Oral Suspension (Vol. 6 of 6) Piperazine Citrate Syrup Pyrantel Pamoate Oral Suspension Jayne’s PW Vermifuge Pyrantel Pamoate Oral Suspension Pyrantel Pamoate Oral Suspension Pyrantel Pamoate oral

170161

170162 170207 17FPAI 17FPAII

Memorandum from the Division of Drug Experience to the Division of OTC Drug Evaluation Pfizer Internatonal

Suspension Adverse Peactions to Antiminth, Povan, Piperazine Citrate, and Gentian Violet Drug Experience Report References Panel Administrator’s File (1.1 – 1.8) Panel Administrator’s File (Correspondence)

Exocrine Pancreatic Insufficiency Drug Products For Over-The-Counter Human Use Administrative Record (Docket No. 79N-0379)

Index to Panel Submissions

OTC Vol Number 170034 170130 170144 170145 170146 170182 17BPAI

Submitted By Winthrop Labs. Parke-Davis and Co. Hoechst-Roussel Pharm. Hoechst-Roussel Pham. Hoechst-Roussel Pharm.

Subject Stamyl tablets Panteric capsules, tablets, granules Festal tablets (Volume 1 of 3) Festal tablets (Volume 2 of 3) Festal tablets (Volume 3 of 3) References Panel Administrator’s File

Hypophosphatemia and Hyperphosphatemia Drug Products For Over-The-Counter Human Use Administrative Record (Docket No. 80N-0395)

Index to Panel Submissions

OTC Volume Number 170005 170043 170211 17HPAI

Submitted By Wyeth Laboratories Inc. Wyeth Laboratories Inc.

Subject Basaljel Phosphaljel References Panel Administrator’s File (1.1 – 1.9)

Smoking Deterrent Drug Products For Over-The-Counter Human Use Administrative Record (Docket No. 81N-0027)

OTC Volume Number 170001 170002 170038 170129 170168 170169 170170 170173 170178 170229 17KPAI

Submitted By Health Sciences Association Health Sciences Association Campana Corporation Edgefield Corporation S.A. Cravotta Company Friend, Perles, Dorfman and Kleefeld Friend, Perles, Dorfman and Kleefeld Buffalo District, FDA Edgefield Corporation

Subject Nicoprive (Volume 1 of 2) Nicoprive (Volume 2 of 2) Bantron Tabmint Chewing Gum “I Quit” Nicocortyl (Volume 1 of 2) Nicocortyl (Volume 2 of 2) Nicocortyl Tabmint Chewing Gum References Panel Administrator’s File

Insect Repellent Drug Products for Over-the-Counter Oral Human Use Administrative Record (Docket No. 81N-0040) Index to Panel Submissions

OTC Volume Number 170174

Submitted By FDA

Subject Journal articles and textbook abstracts

17NPAI

FDA

Panel Administrator’s File (1.1 – 1.8)

Drug Products For Over-the-Counter Human Use For the Treatment of Acute Toxic Ingestion Administrative Record (Docket No. 81N-0050)

Index to Panel Submission

OTC Volume No. 170139 170150 170151 170227 170PAI

Submitted By Bowman Pharmaceuticals, Inc. Requa manufacturing Company, Inc. Regua Manufacturing Company, Inc. FDA FDA

Subject Poison Control Kit Activated Charcoal Activated Charcoal References (Cited and Uncited) Panel Administrator’s File

Orally Administered Drug Products For the Treatment Of Fever Blisters for Over-the-Counter Human Use Administrative Record (Docket No. 81N-0060) Index to Panel Submissions OTC Volume Number 170052 170180 170185 170228 17IPAI Submitted By Hynson, Westcott and Dunning, Inc. Hynson, Westcott and Dunning, Inc. Hynson, Westcott and Dunning, Inc. Subject Lactinex Lactinex Lactinex References Panel Administrator’s File

Deodorant Drug Products for Internal Use for Over-the-Counter Human Use Administrative File (Docket No. 81N-0064) Index to Panel Submissions OTC Volume No. 170014 170125 170151 170171 170172 Submitted By Rystan Company Inc. Brooklyn-Cumberland Medical Center Requa manufacturing Co., Inc. Parthenon Co. inc. Norma Gill, et. Al. Subject Derifil Tablets Chloresium Tablets Activated Charcoal Activated Charcoal Activated Charcoal Bismuth Subgallate “Odor Barriers”

170179 170226 17PPAI

Requa maufacturing Co. Inc. FDA FDA

Activated Cahrcoal References Panel Administrator’s File

Digestive Aid Drug Products For Over-the-Counter Human Use Administrative Record (Docket No. 81N-0106)

Index to Panel Submissions

OTC Volume No. 170003

Submitted By Van Patten Pharmaceutical

Subject Alliman Tablets

170006 170017 170018 170019 170020 170023 170034 170042 170049 170053 170054 170055 170058 170059 170061 170062 170063 170065 170074 170075 170098 170100 170106 170120 170128 170130 170131 170135 170136 170137 170140

Co. Chattem, Inc. Requa manufacturing Co., Inc. Reed & Carnrick Pharmaceuticals Reed & Carnrick Pharmaceuticals Reed & Carnrick Pharmaceuticals Winthrop Products Inc. Winthrop Products Inc. Purdue Frederick Co. Dorsey Laboratories Lewis_Howe Company Warner/Chilcott Signet Laboratories Inc. Lewis-Howe Company Warner/Chilcott Warner-Lambert Company Requa Manufacturing Co., Inc. Warner/Chilcott Requa Manufacturing Co., Inc. Warner-Lambert Company Winthrop Products Inc. Lewis-Howe Company Carter Products Winthrop Products Inc. Lewis-Howe Company Warner-Lambert Company Parke-Davis & Co. Reed & Carnrick Pharmaceuticals Palafox Laboratories, Inc. Reed & Carnrick Pharmaceuticals Warner-Lambert Company Bowman Pharmaceuticals Inc. The Rilox Company Father Francis’ Herbs Warner-Lambert Company

Cardui Liquid Activated Charcoal Tablets and Capsules, Charcoal Tablets Phazyme Tablets Phasil Tablets Laxsil Liquid Acidol-Pepsin Capsules Stamyl Tablets ProBilagol Liquid Kanulase Tablets Tums and Dicarbosil Tablets Gelusil Tablets and Liquid Dihepatone Tablets Tums and Dicarbosil Tablets Gelusil Tablets and Liquid Rolaids Tablets Activated Charcoal Tablets and Capsules, Charcoal Tablets Gelusil Tablets and Liquid Activated Charcoal Tablets and Capsules, Charcoal Tablets Bromo-Seltzer Granules Stamyl Tablets Tums ad Dicarbosil tablets Gastroenterase Tablets Stamyl Tablets Tums and Dicarbosil Tablets Hydrate Magnesium Aluminate Activated Sulfate Liquid & Tablets Panteric Capsules, Tablets and Granules Phazyme Tablets Palagastra Liquid Phazyme Tablets Rolaids Tablets Controflex Phosphorated Syrup Brodie’s Cordial Liquid Medicinal Tea No. 1 & No. 3 Hydrate Magnesium Aluminate Activated Sulfate Liquid & Tablets

170142

170143 170144 170145 170146 170151 170152 170154 170156 170159 170230 170231 170232 17GPAI 17GPAII

Requa Manufacturing Co., Inc. Hoechst-Roussel Pharmaceuticals Inc. Hoechst-Roussel Pharmaceuticals Inc. Hoechst-Roussel Pharmaceuticals Inc. Requa Manufacturing Co., Inc. Requa Manufacturing Co., Inc. Requa Manufacturing Co., Inc. Warner-Lambert Company Reed & Carnrick Pharmaceuticals

Activated Charcoal Tablets and Capsules, Charcoal Tablets Festal Tablets Festal Tablets Festal Tablets Activated Charcoal Tablets and Capsules, Charcoal Tablets Activated Charcoal Tablets and Capsules, Charcoal Tablets Activated Charcoal Tablets and Capsules, Charcoal Tablets Roliads Tablets Phazyme Tablets Cited References A – H Cited References J – Z Unicited References Panel Administrator’s File (1.1 – 1.6) Panel Administrator’s File (Correspondence 1973-1981)

ORALLY ADMINISTERED DRUG PRODUCTS FOR RELIEF OF SYMPTOMS ASSOCIATED WITH OVERINDULGENCE IN ALCOHOL AND FOOD FOR OVER-THE-COUNTER HUMAN USE ADMINISTRATIVE RECORD (DOCKET NO. 82N-0166) INDEX TO PANEL SUBMISSIONS

OTC Volume No. 170015 170016 170107 170108 170109 170110 170111 170112 170113 170114 170115 170116 170117 170118 170123 170132 170151 170175 170177 170181 170187 170188 170189 170190 170191 170192 170193 170194 170195 170196 170197 170198 170199 170200 170201

Submitted By Schmid Laboratories, Inc. Cary Corporation Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Requa manufacturing Company, Inc. Lemmon Company Warner-Lambert Company Requa Manufacturing Company, Inc. Norwich Eaton Pharmaceuticals Cary Corporation Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc.

Subject Fructose tablets Chaser tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Requa’s Activated Charcoal tablets and capsules Quick. Over capsules Bromo-Seltzer granules Requa’s Activated Charcoal tablets and capsules Pepto-Bismol Liquid Chaser tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets

170202 170203 170204 170205 170206 170208 170212 170213 170214 170220 170236 170237 170238 17LPAI 17LPAII

Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Norwich Eaton Pharmaceuticals Norwich Eaton Pharmaceuticals Miles Laboratories, Inc. Miles Laboratories, Inc. Miles Laboratories, Inc. Schmid Laboratories, Inc.

Alka-Seltzer tablets Alka Seltzer tablets Alka Seltzer tablets Alka Seltzer tablets Pepto-Bismol liquid Pepto-Bismol liquid Alka-Seltzer tablets Alka-Seltzer tablets Alka-Seltzer tablets Fructose tablets Cited References Uncited References (A through I) Uncited References (J through Y) Panel Administrator’s File (Sections 1.1 – 1.6) Panel Administrator’s File (Correspondence 1974 through 1981)

QUININE FOR THE TREATMENT OF NOCTURNAL LEG MUSCLE CRAMPS FOR OVER-THE-COUNTER HUMAN USE ADMINISTRATIVE RECORD (DOCKET NO. 77N-0094)

INDEX TO PANEL SUBMISSIONS

OTC Volume No. 170050 170234 17QPAI

Submitted By Purex Corporation FDA-Generated Material

Subject Quinine sulfate capsules Miscellaneous Information Panel Administrator’s File

APHRODISIAC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ADMINISTRATIVE RECORD (DOCKET NO. 80N-0419)

INDEX TO PANEL SUBMISSIONS

OTC Volume No. 17JPAI

Submitted By

Subject Panel Administrator’s File

DRUG PRODUCTS TO TREAT THE SYMPTOMS ON BENIGN PROSTATIC HYPERTROPHY FOR OVER-THE-COUNTER HUMAN USE ADMINISTRATIVE RECORD (DOCKET NO. 82N-0168)

INDEX TO PANEL SUBMISSIONS

OTC Volume No. 170233 17RPAI

Submitted By FDA-Generated material

Subject Miscellaneous Information Panel Administrator’s File

Weight control drug products for Over-the-Counter Human Use Administrative Record (Docket No. 81N-0022)

INDEX TO PANEL SUBMISSIONS

OTC Volume No. 170009 170010 170012 170013 170028 170029 170030 170037 170041 170044 170047 170048 170051 170056 170057 170060 170067 170082 170093 170094 170096 170119 170126 170127 170141 170147 170148 170149 170153 170155 170164 170166 170235 17EPAI

Submitted By Thompson Medical Co., Inc. Thompson Medical C., Inc. Marion Laboratories, Inc. Thompson Medical Co., Inc. Fox Pharmacal, Inc. Fox Pharmacal, Inc. Thompson Medical Co., Inc. Thompson Medical Co., inc. Alleghany Pharmaceutical Corp. Marion Laboratories, Inc. Thompson Medical Co., Inc. Thompson Medical Co., Inc. Marion Laboratories, Inc. Purex Corp. Fox Pharmacal, Inc. Thompson Medical Co., Inc. Thompson Medical Co., Inc. Marion Laboratories, Inc. Thompson Medical Co., Inc. Thompson Medical Co., Inc. Thompson Medical Co., Inc. Marion Laboratories, Inc. Thompson Medical Co., Inc. Thompson MedicalCo., inc. Marion Laboratories, Inc. Fox Pharmacal, Inc. Fox Pharmacal, Inc. Fox Pharmacal, Inc. Fox Pharmacal, Inc. Thompson Medical Co., Inc. Fox Pharmacal, Inc. Alleghany pharmaceutical Corp.

Subject Appedrine tablets Slim-Line candy Pretts tablets Slim-Line candy Odrinex tablets Odrinex tablets Prolamine capsules Slim-Mint gum Hungrex w/P.P.A. tablets Pretts tablets Appedrine tablets Slim-Line candy Pretts tablets Slendron capsules Odrinex tablets Appedrine tablets Appedrine tablets Pretts tablets Slim-Mint gum Slim-Line candy Prolamine capsules Pretts tablets Weight Control Information Slim-Mint gum and Slin-Line candy Pretts tablets Super-Odrinex tablets Super-Odrinex tablets Super-Odrinex tablets Super-Odrinex tablets Phenylpropanolamine Super-Odrinex tablets Permathene-12 capsules Cited and uncited References Panel Administrator’s File

17EPAII 17EPAIII

(1.1 – 1.6) Panel Administrator’s File (Correspondence 1975-1977) Panel Administrator’s File (Correspondence 1977-1982) ORALLY ADMINISTERED MENSTRUAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ADMINISTRATIVE RECORD (DOCKET NO. 82N-0165)

OTC Volume No. 170004 170022 170025 170026 170027 170031 170032 170046 170066 170076 170077 170078 170079 170080 170081 170095 170097 170121 170209 170210

Submitted By Whitehall Laboratories, Inc. Sterling Drug Inc. USV Pharmaceutical Corporation Chattem, Inc. Chattem, Inc. The Emko Company Thompson Medical Company, Inc. Thompson Medical Company, Inc. Pfizer Pharmaceuticals Cooper Laboratories, Inc. Cooper Laboratories, Inc. Cooper Laboratories, Inc. Cooper Laboratories, Inc. Cooper Laboratories, Inc. Cooper Laboratories, Inc. Thompson Medical Company, Inc. McNeil Laboatories, inc. Pfizer pharmaceuticals Chattem, inc. Sterling Drug Inc.

Subject Trendar tablets Midol tablets Femicin tablets Neo Bromth tablets Pamprin tablets, Cardui tablets, and Zodiex tablets Sunril capsules Aqua-Ban tablets Aqua-Ban tablets Femanol liquid Lydia E. Pinkham tablets and Vegetable Compound liquid Lydia E. Pinkham tablets and Vegetable Compound liquid Lydia E. Pinkham tablets and Vegetable Compound liquid Lydia E. Pinkham tablets and Vegetable Compound liquid Lydia E. Pinkham tablets and Vegetable compound liquid Lydia E. Pinkham tablets and Vegetable Compound liquid Aqua-Ben tablets Tylenol tablets and Tylenol with Codeine tablets Femanol liquid Pamabrom-containing products Midol tablets

170217 170218 170219 170221 170222 170223 170224 170225 170239 170240 170241 17MPAI 17MPAII

Thompson Medical Company, Inc. Chattem, Inc. Chattem, Inc. Chattem, Inc. Sterling drug inc. Chattem, Inc. Chattem, Inc. Sterling Drug Inc.

Aqua-ban tablets Pyrilamine maleatemenstrual syndrome Pamprin tablets Pamabrom/pyrilamine maleate combinations Midol tablets Pamabrom/pyrilamine maleate combinations Pamprin tablets Midol tablets Cited References (A – H) Cited References (I – Y) Uncited References Panel Administrator’s File (1.1 – 1.6) Panel Administrator’s File (Correspondence)

NO _______IFM___________ VOLUME WAS MADE FOR ________________________________ CHOLECYSTOKINETIC DRUG________________________________________________________ PRODUCTS________________________________________________________________________

TFM VOLUME 17ATFM____________________________ Has been established for STOMACH____________________ ACIDIFIER_______________________________________ _________________________________________________

TFM VOLUME 17FTFM_____________________ Has been established for ANTHELMINTIE_________________ DRUG_PRODUCTS___________________________________ ___________________________________________________

TFM VOLUME 17HTFM_________________ Has been established for HYPOPHOSPHATEMIA_____________ AND HYPERPHOSPHATEMIA___________________________

TFM VOLUME 17JTFM___________________ Has been established for APHRODISIAC__________________________ DRUG PRODUCTS__________________________________________

TFM VOLUME 17OTFM__________________________ Has been established for POISON TREATMENT_________________________ _________________________________________________________________

OTC STIMULANT SUBMISSION

Volume No. 180001 180002 180003 180004 180005 180006 180007 180008

Submitted By FDA Bristol-Myers J.B. Williams “ “ “ “ Jerrard Cosmetics LTD.

Trade Name

Ingredients Caffeine Caffeine Caffeine “ “ “ “ Caffeine

NO-DOZ Viviran “ “ “ “ Love Garden Stimulant

Remarks Literature Search Abstracts “Fast active keep alert Tablets” “Stimulant Tablets” “ “ “ “ “ “ “ “ “Stimulant capsules” “…to enhance your sensual awareness” “…also contains 45 I.V. Vitamin E and 10mg Ginseng” “Helps relieve premenstrual symptoms: swelling weight gain and fatique”

180009

Blair Labs. Inc.

Pre-Mens Forte Tablets

Ammonium Cl Caffeine

ADMINISTRATIVE FILE TOPICAL ANTIBIOTICS

Volume 190001 190002 190003 190004 190005 190006 190007 190008 190009 190010 190011 190012 190013 190014 190015 190016 190017 190018 190019 190020 190021 190022 190023 190024 190025 190026

Company Dow Chemical Squibb Upjohn Upjohn Upjohn Day-Baldwin “ “ “ “ Merrell-National Bederle Pfizer Pfizer FDA Medical Library FDA “ “ Burroughs-Wellcome FDA-Div. Anti-Infective Drugs Industry Task Force “ “ “ “ “ “ “ “ “ “ “ “ “ “ “ Industry Task Force Marion Sulzberger

Subject Neo-Polycin Spectrocin Ointment Baciguent Myciguent Mycitracin Bacitracin-Neomycin Bacitracin Neomycin “3” Antibiotic Bibliography-Antibiotics Bacitracin Achromycin and Aureomycin Bacitracin Terramycin Abstracts-Bibliography-TA Bibliography-TA Topical Antibiotic Ointments Neosporin Ointment Topical Antibiotic Products Supporting Reprint A-E “ “ F-K “ “ L-N “ “ O-R “ “ S-Z Addendum to Safety & Efficacy Neomycin sensitivity

190027 Reference Topical Antibiotic A-D E-G H-J K-L M-Q R-Z

Wm. F. Schorr, M.D.

Polmycin allergy

Transcript – May 16, 1975 Transcript – June 27, 1975-Scheuplein Summary Minutes of Panel Meetings Antimicrobial II – Fungal infections for the Feet Antimicrobial II – Draft of Panel report (#9 (8-76))