Psoriasis, Dermatitis & Rashes Cream

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

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Ingredient activ:
Aloe vera,Carica papaya,Stellaria media
Disponibil de la:
SE Operations Pty Ltd
Statutul autorizaţiei:
Listed
Numărul autorizaţiei:
350986

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Public Summary

Summary for ARTG Entry:

350986

Psoriasis, Dermatitis & Rashes Cream

ARTG entry for

Medicine Listed

Sponsor

SE Operations Pty Ltd

Postal Address

Office 7 36 Ord Street, WEST PERTH, WA, 6005

Australia

ARTG Start Date

7/12/2020

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.

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 . Psoriasis, Dermatitis & Rashes Cream

Product Type

Single Medicine Product

Effective Date

7/12/2020

Permitted Indications

Traditionally used in Western herbal medicine to decrease/reduce/relieve itchy/prickling skin associated with mild eczema/dermatitis

Traditionally used in Western herbal medicine to decrease/reduce/relieve symptoms of mild eczema/dermatitis

Traditionally used in Western herbal medicine to decrease/reduce/relieve symptoms of mild psoriasis

Traditionally used in Western herbal medicine to decrease/reduce/relieve skin dryness

Traditionally used in Western herbal medicine to soothe/relieve skin inflammation

Traditionally used in Western herbal medicine to decrease/reduce/relieve skin irritation

Traditionally used in Western herbal medicine to antipruritic/Relieves itchy skin

Traditionally used in Western herbal medicine to relieve red skin rash

Traditionally used in Western herbal medicine to vulnerary/wound healing

Traditionally used in Western herbal medicine to helps healing of mild skin burn/sunburns

Traditionally used in Western herbal medicine to enhance/improve healing of minor skin wound/cuts/scratches/abrasions

Indication Requirements

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

Product presentation must only refer to 'mild' burns.

Product presentation must only refer to mild eczema.

If product is indicated for skin burn, Label statement: Only to be used for minor burns after initial first aid treatment, medical advice should be sought for

serious burns.

Product presentation must only refer to mild psoriasis

If product is indicated for skin burn, Label statement: Immediate treatment of burns should be application of cold water for ten minutes (or words to that

effect).

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

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

(If medicine contains one benzoate) Contains [insert name of benzoate] Or (If medicine contains two or more benzoates) Contains benzoates [or words to

that effect].

Public Summary

Page 1 of

Produced at 11.01.2021 at 09:09:49 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

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

Aloe vera leaf Juice dry

5 mg/g

Equivalent: Aloe vera (Fresh)

1000 mg/g

Carica papaya fruit Juice fresh

600 mg/g

Equivalent: Carica papaya (Fresh)

600 mg/g

Stellaria media herb Extract soft concentrate

40 mg/g

Equivalent: Stellaria media (Dry)

200 mg/g

Other Ingredients (Excipients)

aluminium magnesium silicate

calcium gluconate monohydrate

carrageenan

cetostearyl alcohol

citric acid

coco-caprylate

dl-alpha-tocopheryl acetate

Fragrance (perfume)

gluconolactone

glycerol

glyceryl caprylate

glyceryl monostearate

glyceryl stearate citrate

medium chain triglycerides

purified water

Simmondsia chinensis

sodium benzoate

sodium citrate dihydrate

sodium hydroxide

titanium dioxide

xanthan gum

yellow beeswax

© 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 09:09:49 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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