BIO-LOGICAL ZINC SOLUTION

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
zinc sulfate heptahydrate
Available from:
Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies
Authorization status:
Listed
Authorization number:
352698

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Public Summary

Summary for ARTG Entry:

352698

BIO-LOGICAL ZINC SOLUTION

ARTG entry for

Medicine Listed

Sponsor

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

Postal Address

PO Box 702, BRAESIDE, VIC, 3195

Australia

ARTG Start Date

8/01/2021

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.

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 . BIO-LOGICAL ZINC SOLUTION

Product Type

Single Medicine Product

Effective Date

8/01/2021

Permitted Indications

Maintain/support (state vitamin/mineral/nutrient) levels in the body

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency

Maintain/support skin health

Maintain/support wound healing

Indication Requirements

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not

replace a balanced diet.

Label statement: If symptoms persist, talk to your health professional.

If product is indicated for supplementation, Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin

and/or mineral supplements should not replace a balanced diet.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

(If the medicine contains one sorbate) Contains [insert name of sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that

effect].

If symptoms persist consult your healthcare practitioner (or words to that effect).

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).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Neither child resistant

Not recorded

Public Summary

Page 1 of

Produced at 11.01.2021 at 07:23:36 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 www.tga.gov.au for contact information

closure nor restricted

flow insert

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Oral Liquid, solution

Route of Administration

Oral

Visual Identification

Active Ingredients

zinc sulfate heptahydrate

50 mg/mL

Equivalent: zinc

11.3 mg/mL

Other Ingredients (Excipients)

hydrochloric acid

potassium sorbate

purified water

© 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 11.01.2021 at 07:23:36 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 www.tga.gov.au for contact information

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