Baby Teething Gel

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

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Active ingredient:
Clove Bud Oil,Matricaria chamomilla
Available from:
Evolution Health Pty Ltd
Authorization status:
Listed
Authorization number:
321742

Public Summary

Summary for ARTG Entry:

321742

Baby Teething Gel

ARTG entry for

Medicine Listed

Sponsor

Evolution Health Pty Ltd

Postal Address

6 McArthur Street,WEST FOOTSCRAY, VIC, 3012

Australia

ARTG Start Date

14/08/2019

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. Baby Teething Gel

Product Type

Single Medicine Product

Effective date

14/08/2019

Permitted Indications

Traditionally used in Western herbal medicine to decrease/reduce/relieve gum soreness/pain/discomfort

Traditionally used in Western herbal medicine to decrease/reduce/relieve teething/tooth pain

Indication Requirements

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

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

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

(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].

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Route of Administration

Oral Application

Visual Identification

Public Summary

Page 1 of

Produced at 29.08.2019 at 04:54:34 AEST

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

Active Ingredients

Clove Bud Oil

210 mg/g

Matricaria chamomilla

.05 mg/g

Equivalent: Matricaria chamomilla (Dry)

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 29.08.2019 at 04:54:34 AEST

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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