Medihoney

Main information

  • Trade name:
  • Medihoney Natural Eczema Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Medihoney Natural Eczema Cream
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221573
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221573

Medihoney Natural Eczema Cream

ARTG entry for

Medicine Listed

Sponsor

Comvita Australia Pty Ltd

Postal Address

767 Bischoffs Road,COOMINYA, QLD, 4311

Australia

ARTG Start Date

24/03/2014

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. Medihoney Natural Eczema Cream

Product Type

Single Medicine Product

Effective date

24/03/2014

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

to that effect].

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

Standard Indications

For the symptomatic relief of eczema. [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.

Specific Indications

Protects and soothes dry skin and minor skin irritations.

Assists in the management of dry skin and minor skin irritations.

Antibacterial honey assists with the control of skin colonising bacteria associated with eczema and dermatitis.

Clinical research has shown Aloe barbadensis (syn: Aloe vera) to be a natural effective ingredient for improving skin hydration.

Chamomile (Matricaria recutita) is recommended for mild skin irritation.

The cream assists in the management of dry skin conditions by providing moisturisers that replenish and condition dry skin.

Helps maintain the skin's barrier properties and maintain skin moisture.

Helps relieve itching.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Tube

Not recorded

Not recorded

Not recorded

Neither child resistant

Not recorded

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:51:59 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

Cream

Route of Administration

Topical

Visual Identification

Active Ingredients

Aloe vera

5 mg/g

Equivalent: Aloe vera (Fresh)

1 g/g

Honey

300 mg/g

Matricaria chamomilla

20 mg/g

Equivalent: Matricaria chamomilla (Dry)

10.5 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 12:51:59 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