G & W Aust

Main information

Documents

Localization

  • Available in:
  • G & W Aust AcneClear
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214248
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214248

G & W Aust AcneClear

ARTG entry for

Medicine Listed

Sponsor

G & W Aust Pty Ltd

Postal Address

10 Olive Street,FAIRFIELD, NSW, 2165

Australia

ARTG Start Date

5/09/2013

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. G & W Aust AcneClear

Product Type

Single Medicine Product

Effective date

5/09/2013

Warnings

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

Standard Indications

Treatment of acne. [Warning S required]

May assist blood circulation.

May assist in the management of mild to moderate acne.

Specific Indications

Helps control minor skin infection.

May have anti-inflammatory effect.

Supports or helps in the maintenance of healthy immune function.

May have anti-oxidant effects.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Public Summary

Page 1 of

Produced at 23.11.2017 at 08:33:44 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

Route of Administration

Oral

Visual Identification

Active Ingredients

Angelica dahurica

52.3 mg

Equivalent: Angelica dahurica (Dry)

350 mg

Astragalus membranaceus

32 mg

Equivalent: Astragalus membranaceus (Dry)

400 mg

Crataegus cuneata

33.33 mg

Equivalent: Crataegus cuneata (Dry)

Cullen corylifolium

20 mg

Equivalent: Cullen corylifolium (Dry)

500 mg

Glycyrrhiza glabra

10 mg

Equivalent: Glycyrrhiza glabra (Dry)

500 mg

Lycium chinense

10 mg

Equivalent: Lycium chinense (Dry)

200 mg

Oldenlandia diffusa

59.9 mg

Equivalent: Oldenlandia diffusa (Dry)

Paeonia lactiflora

32 mg

Equivalent: Paeonia lactiflora (Dry)

800 mg

Paeonia suffruticosa

32 mg

Equivalent: Paeonia suffruticosa (Dry)

800 mg

Phellodendron amurense

41.7 mg

Equivalent: Phellodendron amurense (Dry)

500 mg

Rehmannia glutinosa

32 mg

Equivalent: Rehmannia glutinosa (Dry)

160 mg

Salvia miltiorrhiza

166.67 mg

Equivalent: Salvia miltiorrhiza (Dry)

Saposhnikovia divaricata

26 mg

Equivalent: Saposhnikovia divaricata (Dry)

200 mg

Scutellaria baicalensis

48 mg

Equivalent: Scutellaria baicalensis (Dry)

1.2 g

Sophora flavescens

33.4 mg

Equivalent: Sophora flavescens (Dry)

400 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 2 of

Produced at 23.11.2017 at 08:33:44 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