Laboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine Group no, Company Name: Name Product Name: BABY POWDER Shelf Life. 2 years Manufacturing Order No. Batch Size: 25 grams Finishing Order No: Date of Manufacture: Batch Number: Expiry Date Objectives: 1. To manufacture Baby Powder (talc free and scented) by mechanical mixing and Sieving methods, in compliance to CGMP standards. 2 To label the finished product according to FDA requirements Materials: Evaporating Dishes Mettler PE analytical balance Watch glasses Standard Sieves, mesh -100 Test tubes Mortar and Pestle Spatula (porcelain and metal) Zip-lock bag, big Pipets, 1 mL Sifter-top polyethylene plastic Aspirators, container, 25 g Packing and Labeling materials Formulation for 25 grams: Comstarch, USP. Kaolin, USI Sweet Orange essential oi 10.00 drops Ylang-ylang essential oil 5.00 drops Geranium essential o -- 5.00 drops To make A. Dispensing Procedures: 1. Weigh the following; cornstarch and kaolin. Measure. the following, sweet orange oil, ylang-ylang oil and Dispensed by geranium oil. Checked by ‘CEU School of Pharmacy i 2 95|PageLaboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine Compounding Procedure: 2. Triturate cornstarch and kaolin, separately, in a mortar, until it produces an impalpable and lump-free texture 3, Place the powders in a big zip-lock bag Ina test tube, combine the essential oils of Orange Ylang-ylang and Geranium. 4, Add the essential oil mixture, dropwise to the bulk powders in the zip lock bag, pressing the closed bag from time to time with your fingers to remove clumps of powder. 5. Close the zip-lock bag and tumble the powders for 10 minutes. 5. Let the essential oil-infused powders (contained in the zip-lock bag) stand for 24 to 48 hours. 6. Remove the bulk powders from the bag and pass through a number 100 mesh sieve. 7. Fill the product in a clean, previously tared sifter-top or shaker type container. 8. Affix the label and place finished product in the unit box. Done by: Checked by: Done by: Checked bj Done by: Checked by: Done by: Checked by: ___ Done by: Checked by: ___ Done by Checked by: Filled by: Checked by: Finished by: Checked by. ‘CEU School of Pharmacy ‘96|/PageLaboratory Guide for Manufacture of Drugs, Cosmetics and Veterinary Medicine Each gram contains: grams ‘Comstarch—— Brand name Kaolin————— BABY POWDER Tale - Free Scented Directions for Use: | Dust on skin afterevery | Manufactured by: bath or diaper change to protect against rashes Company Name | and chafing. CEU Mendiola, Manita ‘CEU School of Pharmacy Lot no, Date Mf'd: Expiry Date: FOR EXTERNAL USE Storage: Store at a temperature not exceeding 40°C. ‘o7|Page