Public Summary

Summary for ARTG Entry: 158271 ErectOMax

ARTG entry for Medicine Listed

Sponsor Caruso's Natural Health Pty Ltd

Postal Address PO Box 310,HORSLEY PARK, NSW, 2175
Australia
ARTG Start Date 5/01/2009
Product category Medicine
Status Active
Approval area Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in
the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,
(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is
sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be
kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records
to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted
in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

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of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors
of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified
of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine
outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National
Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. ErectOMax
Product Type Single Medicine Product Effective date 4/04/2013

Warnings

If symptoms persist consult your healthcare practitioner (or words to that effect).
Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.
WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large
amounts or for a long period (or words to that effect).

Standard Indications

For vitamin (may state the vitamin) supplementation.

Male support. Nutritional and herbal support designed to support and enhance masculine needs.
Beneficial during times of stress. [Warning S required]
Herbal blend which helps relieve stress of study or work. [Warning S required]
Male support. Balances and supports normal male physiology and function.
Male support. May be beneficial to men in satisfying physiological requirements of the male body.

Specific Indications

Zinc:
-Zinc may help to stabilize cell membranes & protect cells from damage. Zinc may be beneficial for minor wound healing & for assisting with a normal
functioning immune system
-Zinc is an essential anti-oxidant enzyme which may protect cells from damage & breakdown.
-Zinc is involved in 100's of enzymatic reactions.
-Zinc may help to metabolise carbohydrates & protein.
-Zinc deficiencies may lead to a depletion in seminal volume in normal healthy men
-Zinc deficiencies may cause low levels of testosterone in men
-Zinc promotes healthy sperm motility in normal healthy men
-A loss of libido may occur due to marginal zinc deficiencies
-Zinc is the most critical trace mineral for male sexual performance, healthy sperm formation and healthy sperm motility in normal healthy men
-Zinc deficiencies decrease testosterone levels and sperm levels
-Zinc deficiency is a common mineral deficiency that is known to interfere with sexual performance.
-Zinc may play an important role in modulating serum testosterone levels in normal men
-Zinc levels may be correlated to testosterone in the body.

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 -Restriction of dietary zinc may result in decreases in serum testosterone levels.
-Supplementation of zinc may increase free testosterone.
Testosterone:
-Testosterone levels decline in men with age
-Testosterone may lose it's biological activity when it binds to SHBG
-Supplementation with a combination of Zinc, Magnesium and Vit
B6 may improve anabolic hormone profile and improve muscle function of weight trainers.
-Supplementation with a combination of Zinc, Magnesium and Vit
B6 may maintain healthy testosterone levels in men
-Supplementation with a combination of Zinc, Magnesium and Viit B6 may help maintain healthy free testosterone levels, total testosterone levels, and
may also increase muscle strength in the Hamstrings and Quadriceps.
-Supplementation with Zinc or Magnesium may improve strength and muscle metabolism and efficiency.
-Testofen is a Fenugreek Extract which has been standardised for Fenuside
-Testofen supplementation may balance free testosterone levels in weight training individuals
-Testofen may assist to maintain normal healthy testosterone levels in men
-Supplementation with Testofen may decrease skin fold thickness in the Triceps and Thighs without increasing body weight, hence increasing muscle
mass.
-Supplementation with Testofen may decrease Blood Urea Nitrogen levels therefore reducing muscle mass breakdown
-Fenugreek has been used Traditionally for Thousands of years, dating back to Egyptian times
-May assist with libido
-May help increase sexual desire
-May help increase sexual arousal
-May help increase sexual activity
-May help increase muscle strength
May help increase energy
-May help with general wellbeing
-Nettle root binds to SHBG and may reduce the ability of SHBG to bind to free testosterone
-Stinging Nettle may increase the effects of androgenic hormones by blocking access to sex hormone binding globulin (SHBG)
-Stinging Nettle may reduce the binding capacity of sex hormone binding globulin (SHBG)
-Oates contains saponins in the form of Avenacosides
-Oates may increase energy and stamina due to the levels of Polysaccharides in the herb.
Panax:
-In Traditional Chinese Medicine, Korean Ginseng was used as a reproductive tonic & aphrodisiac. It was used for promoting sexual performance in both

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males and females.
-Panax Ginseng may help the body adapt with physical & mental stressors.
-Panax Ginseng may help promote an overall improvement in physical & mental performances/capabilities.
[NERV2] Beneficial during times of stress.
[NERV6] Herbal blend which helps relieve stress of study or work.
-Panax Ginseng may help counter the effects of stress & may help enhance physical & mental performance.
-Korean Ginseng may help support in the relief of the symptoms associated with stress & fatigue.
-Panax Ginseng may help support the male reproductive system.
-Korean Ginseng may assist in balancing & supporting healthy male & female physiology & function.
-Panax Ginseng may help to enhance libido levels.
-Panax Ginseng may help support the male reproductive system.
-Korean Ginseng may help support in the relief of the symptoms associated with stress & fatigue.
-Korean Ginseng is considered the most potent Qi or energy tonic in traditional Chinese medicine.
-Ginseng may enhance libido or sexual desire
-Ginseng may enhance and assist sexual performance
-Panax is indicated for use in low vitality, enhancement of physical performance & sexual performance.
-Panax may help support healthy immunity
-Ginseng has been shown to aid the body's resistance to stress, acting as an adaptogen
-Panax Ginseng may help to enhance libido levels.
-May enhance sexual performance
-May assist with healthy sperm production
-Traditionally used as an adaptogen
-Ginseng has been shown to aid the body's resistance to stress, acting as an adaptogen
-Korean Ginseng may help support in the relief of the symptoms of stress & fatigue.
-Adaptogenic
-May be used as a restorative agent for enhancement of mental & physical capacities, in cases of weakness, exhaustion, tiredness

Additional Product information

Pack Size/Poison information

Pack Size Poison Schedule
Components
1. Formulation 1

Dosage Form Tablet, film coated

Route of Administration Oral
Visual Identification

Active Ingredients

Avena sativa 100 mg

Equivalent: Avena sativa (Dry) 1000 mg
Magnesium aspartate dihydrate 225 mg
Panax ginseng 135 mg
Equivalent: Panax ginseng (Dry) 1.35 g
pyridoxine hydrochloride 6 mg

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Visit www.tga.gov.au for contact information
 Trigonella foenum-graecum 300 mg
Equivalent: Trigonella foenum-graecum (Dry) 9.9 g
Urtica dioica 62.5 mg
Equivalent: Urtica dioica (Dry) 1000 mg
zinc amino acid chelate 75 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 3 of 3 Produced at 31.12.2017 at 10:55:09 AEDT

This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information