Main information



  • Available in:
  • Mediherb Zinc Protect
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221703
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Mediherb Zinc Protect

ARTG entry for

Medicine Listed


Integria Healthcare Australia Pty Ltd

Postal Address



ARTG Start Date


Product category




Approval area

Listed Medicines


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


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

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.


1. Mediherb Zinc Protect

Product Type

Single Medicine Product

Effective date



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).

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

For practitioner dispensing only.

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

Standard Indications

Aids, assists or helps in the maintenance or improvement of general well-being.

Prevention/treatment of vitamin [XX] and/or mineral [YY] and/or nutritional deficiencies (This indication is not be to used for the treatment of iron

deficiency conditions).

For mineral (may state the mineral) supplementation.

For the symptomatic relief of minor wounds (cuts, scratches, abrasions).

For vitamin (may state the vitamin) supplementation.

Specific Indications

For the maintenance of good health.

For zinc supplementation.

To help replenish zinc status, especially for those with increased needs including adolescents, pregnant and lactating women, the elderly, athletes and


Helps to maintain healthy skin.

Zinc, vitamin C and vitamin E may help to promote minor wound healing (cuts, scratches, abrasions).

Zinc, vitamin C and vitamin E are involved in wound healing.

Zinc, beta-carotene, vitamins C & E, manganese and selenium all play a role in the antioxidant defence mechanism of the body.

Antioxidant / Has anti-oxidizing effect.

Antioxidants to help reduce damage caused by uncontrolled free radicals.

Provides cofactors for the production of the neurotransmitters serotonin, GABA, dopamine and noradrenaline.

Helps to maintain immune function / Supports a healthy immune system.

For vitamin B6, vitamin C, vitamin E and beta-carotene supplementation

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:23:36 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 for contact information

Prevention/treatment of vitamin B6, zinc and selenium deficiencies

For zinc, selenium and manganese supplementation.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration


Visual Identification

Active Ingredients

Ascorbic acid

50 mg


2 mg

d-alpha-Tocopheryl acid succinate

41.32 mg

Manganese amino acid chelate

20 mg

pyridoxine hydrochloride

40 mg


65 microgram

zinc amino acid chelate

90 mg

Zinc ascorbate

79.5 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

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:23:36 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 for contact information