Cream

Main information

Documents

Localization

  • Available in:
  • Cream for Eczema & Psoriasis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219158
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219158

Cream for Eczema & Psoriasis

ARTG entry for

Medicine Listed

Sponsor

A Bit Hippy Pty Ltd

Postal Address

56 Dover Drive,BURLEIGH HEADS, QLD, 4220

Australia

ARTG Start Date

13/01/2014

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

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. Cream for Eczema & Psoriasis

Product Type

Single Medicine Product

Effective date

13/01/2014

Warnings

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

Standard Indications

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

Treatment of minor skin disorders such as wounds, scratches, eczema, dermatitis, bruising, cuts and abrasions. [Warning S required]

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

Relief of the effects of psoriasis on the skin. [Warning S required]

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

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

For the symptomatic relief of dry skin.

Treatment of dry or inflamed skin conditions. [Warning S required]

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

May assist in the management of dry skin.

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

Treatment of the effects of psoriasis on the skin. [Warning S required]

Relief of the symptoms of eczema. [Warning S required]

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

Specific Indications

Anti-fungal, anti-yeast, anti-inflammatory (where associated with product name and/ or coded claims and /or when presented in conjunction with

representations of mild and moderate topical skin conditions / wounds)

For symptomatic relief of Atopic Dermatitis (Eczema) / Psoriasis. For symptomatic relief of Atopic Dermatitis (Eczema), Seborrheic Dermatitis &

Psoriasis.

May / Help stimulate skin metabolism

Helps to protect and heal inflamed skin. Skin conditioning.

Suitable for Fungal and Yeast skin conditions. Apply topically as required to keep skin moist and healthy, helps to manage dermal inflammation caused

by eczema, psoriasis and yeast mediated conditions, helps to remove the crust associated with eczema, psoriasis and yeast mediated skin conditions.

Helps to stimulate natural immune function. Wound Healing. Antioxidant. Gently stimulates and soothes inflamed skin. Antiseptic, anti-inflammatory and

astringent properties, in / for (external) minor skin disorders. Mild Anti-Inflammatory

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:52:45 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

Anti-Inflammatory....... Natural solution to........

the natural anti-inflammatory and anti-fungal cream for symptomatic relief of....( associated with coded claims &/or product name)

Rashes can be caused by all sorts of reasons. Eczema, Seborrheic dermatitis, Yeast, alternative to chemical based creams. Evidence based, natural

Ingredients

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Cream

Route of Administration

Topical

Visual Identification

Active Ingredients

Borago officinalis

35 mg/g

Centella asiatica

10 mg/g

Equivalent: Centella asiatica (Dry)

5 mg/g

Coconut Oil

40 mg/g

Evening Primrose Oil

20 mg/g

Glycyrrhiza glabra

2 mg/g

Equivalent: Glycyrrhiza glabra (Fresh)

20 mg/g

Matricaria chamomilla

10 mg/g

Equivalent: Matricaria chamomilla (Dry)

5 mg/g

Oryza sativa

35 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 26.11.2017 at 03:52:45 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