ZINC

Main information

Documents

Localization

  • Available in:
  • ZINC FIX ORANGE ETHICAL NUTRIENTS
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207794
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207794

ZINC FIX ORANGE ETHICAL NUTRIENTS

ARTG entry for

Medicine Listed

Sponsor

Health World Ltd

Postal Address

PO Box 675,VIRGINIA BC, QLD, 4014

Australia

ARTG Start Date

5/04/2013

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

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. ZINC FIX ORANGE ETHICAL NUTRIENTS

Product Type

Single Medicine Product

Effective date

18/07/2014

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.

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

Standard Indications

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

For mineral (may state the mineral) supplementation.

May reduce the duration of colds. [Warning COLD required]

May reduce the severity and duration of colds. [Warning COLD required]

For the symptomatic relief of allergies. [Warning S required]

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).

May assist in the management of minor wounds (cuts, scratches, abrasions)

For vitamin (may state the vitamin) supplementation.

May assist in the management of upper respiratory tract infections. [Warnings S and COLD required]

For the symptomatic relief of upper respiratory tract infections. [Warnings S and COLD required]

May assist in the management of allergies. [Warning S required]

Specific Indications

Vitamin C reduces severity of upper respiratory tract infections.

Where a zinc deficiency exists, zinc may assist in the healthy development of motor and attention skills in children.

Zinc and vitamin C supplementation supports cellular immune status.

Vitamin C helps maintain healthy connective tissue promoting healthy bones, teeth and skin.

Vitamin C may reduce the severity and duration of upper respiratory tract infection in children.

Public Summary

Page 1 of

Produced at 28.11.2017 at 12:02:09 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

Vitamin C and zinc may improve/enhance immune function.

Zinc fix to replenish zinc levels fast. Highly concentrated and absorbable zinc powder for zinc nutritional deficiencies. Zinc fix contains ingredients which

may: [VIT1] zinc nutritional deficiencies. Assist a healthy immune system. Help maintain healthy hair, skin and nails. Assist in the management of minor

wounds and cuts. Reduce the severity and duration of colds. Reduce the severity of upper respiratory tract infections. Assist the healthy development of

motor and attention skills in children with zinc deficiencies.

Indicated for a category 1 or 2 zinc test response.

Zinc is found in almost every cell of the body and is necessary for the function of over 200 enzymes.

Great tasting. Combination of zinc and vitamin C.

Zinc sulfate for fast replenishment.

An adequate intake of zinc is necessary for normal growth and development in children.

The elderly may require additional zinc.

Zinc helps maintain a healthy appetite.

Zinc and vitamin C may help promote minor wound healing.

A dietary deficiency of zinc may impair the healthy functioning of the immune system in normal healthy individuals.

Vitamin C may maintain healthy gums and improve periodontal health.

Zinc may reduce the frequency of upper respiratory tract infection in children.

Vitamin C is required for the formation of collagen and helps repair skin.

Zinc and vitamin C are antioxidants that help reduce free radical damage.

Zinc may help maintain healthy skin, hair and nails.

Zinc and vitamin C may assist the normal/healthy immune system.

Aids / assists in minor wound healing and repair of skin tissue.

Helps maintain general well-being.

Assists in maintaining healthy hair, skin and nails.

75% of women and 45% of men are zinc deficient. 3 out of 4 women are zinc deficient.

Highly concentrated and absorbable.

Did you know that 75% of your female and 45% of your male customers could be zinc deficient?

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

526.32 mg/g

Dunaliella salina

3.58 mg/g

magnesium phosphate pentahydrate

12.74 mg/g

pyridoxine hydrochloride

2.63 mg/g

Zinc sulfate monohydrate

32.54 mg/g

© 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 2 of

Produced at 28.11.2017 at 12:02:09 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

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

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