Hair

Main information

Documents

Localization

  • Available in:
  • Hair, Skin & Nails Collagen Formula
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218589
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218589

Hair, Skin & Nails Collagen Formula

ARTG entry for

Medicine Listed

Sponsor

Bio Nourish Pty Ltd

Postal Address

PO Box 216,TERRIGAL, NSW, 2260

Australia

ARTG Start Date

16/12/2013

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. Hair, Skin & Nails Collagen Formula

Product Type

Single Medicine Product

Effective date

16/12/2013

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.

Standard Indications

Maintenance of healthy eyes.

Male support. May be beneficial to men in satisfying physiological requirements of the male body.

Male support. Balances and supports normal male physiology and function.

May assist in the maintenance of normal healthy glycaemic controls in healthy individuals.

Helps maintain normal blood/blood tonic (Note: These claims are appropriate for folic acid, vitamin B12 and iron, but must not imply anaemic conditions)

May assist in the maintenance of normal healthy blood sugar/glucose balance in healthy individuals.

May assist in the maintenance of normal healthy blood sugar/glucose levels in healthy individuals.

May help reduce the oxidation of LDL cholesterol.

For vitamin (may state the vitamin) supplementation.

May assist in the maintenance of a normal/healthy LDL:HDL cholesterol ratio.

May assist in the maintenance of cholesterol within the normal/healthy range in healthy individuals and improve the LDL:HDL ratio.

May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals.

May assist in the maintenance of cholesterol within the normal range in healthy individuals.

Maintain health of capillaries.

Protects capillaries.

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

Specific Indications

* Contains essential nutrients for healthy hair and skin.

* Vitamin C is necessary for wound healing.

Public Summary

Page 1 of

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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 is necessary for the maintenance of healthy skin. * Assists in the healing and repair of the skin.

* High levels of silicon are present in the hair, skin and nails.

* Vitamin C is necessary for the manufacture of collagen in the body.

* Vitamin C plays a role in collagen formation.

* Vitamin C supports the development and maintenance of bones.

* Vitamin C supports the development and maintenance of teeth.

* Vitamin C supports the development and maintenance of cartilage.

* Vitamin C supports connective tissue formation.

* Vitamin C is necessary for wound healing.

* Vitamin C is necessary for the maintenance of healthy skin.

* Assists in the healing and repair of the skin.

* Zinc is required for protein synthesis and cell growth.

* Supports healthy skin renewal processes.

* Supports the health and maintenance of the skin.

* Zinc helps to maintain healthy skin function and repair.

* Zinc assists in the maintenance of healthy skin.

* Vitamin C is an important nutritional antioxidant/free radical scavenger.

* As an antioxidant, vitamin C assists in protecting the body from the damaging effects of free radicals.

* Vitamin C is a potent antioxidant that can reduce the risk of cellular damage from free radicals.

* For zinc supplementation.

* Silicon plays a role in the formation of bone and connective tissue.

* Silicon plays a role in the formation of collagen in bone, cartilage and connective tissue.

* Supports healthy bone minerals density.

* Supports healthy vision and eye function.

* Zinc is important for healthy eye function.

* Zinc plays an important role in the visual system.

* Maintains a normal/healthy cardiovascular system.

* Supports red blood cell health.

* Vitamin C may reduce susceptibility to bruising.

* Vitamin C can regenerate oxidized vitamin E in the body.

* Vitamin C is necessary for healthy gums.

* Lifestyle factors such as stress and cigarettes may increase the body's vitamin C requirements.

* Vitamin C improves iron absorption.

* Supports healthy immune system function.

* Supports the health and function of the immune system.

* Contains nutrients that play important roles in the proper functioning of the immune system.

* Pantothenic acid, pyridoxine, and vitamin C are involved in immune system processed in the body.

* Vitamin C is essential for the proper function of the immune system.

* Maintains a normal/healthy immune system.

* Vitamin C maintains immune health by supporting the activity of the white blood cells and antibody response.

* Vitamin C plays a vital role in many immune mechanisms and antibody response.

* Zinc supports healthy immune function.

* Zinc supports the healthy function of the immune system.

* Zinc is important for the health and function of the immune system.

* Zinc is an important nutrient for a healthy immune response.

* Contains nutrients that play an essential role in the production of energy in the body.

* Contains nutrients that play an essential role in the production of ATP/cellular energy.

* Pantothenic acid plays a critical role in energy production.

* Provides nutrients that are essential in the body for the production of energy.

* Contains nutrients that assist in energy metabolism in the body.

* Vitamin C aids in the metabolism of fats and proteins.

* Contains nutrients essential for carbohydrate, protein and fat metabolism.

* Supports healthy metabolism of proteins, carbohydrates and fats in the body.

* Vitamin B6 assists in the metabolism protein/amino acids and fats.

* Pantothenic acid is involved in the metabolism of protein, amino acids and carbohydrates in the body.

* Zinc is involved in protein, carbohydrate and lipid metabolism.

* Contains nutrients essential for healthy nervous system function.

* Supports the health and function of the nervous system.

* Contains nutrients required in the body for nerve cell function.

* Contains pantothenic acid, which is required for proper function of the adrenal gland.

* Pantothenic acid supports the adrenal glands in the making of cortisone and other adrenal hormones that counteract the stress response.

* Zinc is an essential trace mineral that is a component in over 200 enzymes in the body.

* Zinc is necessary for the proper action of many body hormones including sex hormones.

* Zinc supports the health of the male reproductive system.

* Zinc is an important nutrient in supporting male reproductive health and function.

* Zinc is an important mineral for the formation and maturation of spermatozoa.

* Zinc supports the health and function of the female reproductive system.

* Zinc is an essential mineral for healthy ovulation in women.

* Zinc supports healthy hormonal balance.

* Zinc supports healthy testosterone levels in men.

* A comprehensive formula that provides essential nutrients for strong nails, healthy hair and skin.

* It may help strengthen brittle nails and increase nail thickness.

* Promotes the growth of strong, healthy nails.

* Helps to strengthen soft, brittle nails.

* May assist in the management of brittle nails by increasing the thickness of the fingernails.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Public Summary

Page 2 of

Produced at 26.11.2017 at 04:41:47 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

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

200 mg

Biotin

2.5 mg

Calcium pantothenate

10 mg

colloidal anhydrous silica

106.95 mg

Manganese amino acid chelate

2 mg

pyridoxine hydrochloride

8.25 mg

Zinc gluconate

69.7 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

Produced at 26.11.2017 at 04:41:47 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