Baby & Child Teething Gel

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

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Active ingredient:
Aconitum napellus,Actaea spicata,Atropa belladonna,colloidal anhydrous silica,creosote,Citrullus colocynthis,hahnemann's soluble mercury,Matricaria chamomilla,Strychnos nux-vomica
Available from:
Brauer Natural Medicine Pty Ltd
Authorization status:
Listed
Authorization number:
347981

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Public Summary

Summary for ARTG Entry:

347981

Baby & Child Teething Gel

ARTG entry for

Medicine Listed

Sponsor

Brauer Natural Medicine Pty Ltd

Postal Address

PO Box 234, TANUNDA, SA, 5352

Australia

ARTG Start Date

11/11/2020

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 . Baby & Child Teething Gel

Product Type

Single Medicine Product

Effective Date

11/11/2020

Permitted Indications

Traditionally used in Homoeopathic medicine to relieve feelings of general malaise/general debility

Traditionally used in Homoeopathic medicine to relieve weariness/tiredness/fatigue/feeling of weakness

Traditionally used in Homoeopathic medicine to relieve itchy eyes

Traditionally used in Homoeopathic medicine to relieve eye redness

Traditionally used in Homoeopathic medicine to relieve eye soreness

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve watery eyes/excessive lacrimation

Traditionally used in Homoeopathic medicine to decrease/reduce/relieves bleeding gums

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

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve cracks in the corner of the mouth

Traditionally used in Homoeopathic medicine to relieve dry mouth

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve toothache

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve teething/tooth pain in healthy infants over 6 months of age

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve teething/tooth pain in healthy children

Traditionally used in Homoeopathic medicine to antiemetic/Decrease/reduce/relieve vomiting

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve nausea

Traditionally used in Homoeopathic medicine to relieve irritability in children

Traditionally used in Homoeopathic medicine to relieve irritability

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve restlessness/excess nervous energy in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve restlessness/excess nervous energy

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve symptoms of stress

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve nervous tension/unrest

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve symptoms of mild anxiety

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve sleeplessness

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve disturbed/restless sleep in healthy infants over 6 months of age

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve disturbed/restless sleep in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve disturbed/restless sleep

Indication Requirements

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

Public Summary

Page 1 of

Produced at 11.01.2021 at 11:03:41 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

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must not imply or refer to chronic fatigue syndrome.

Product presentation must not imply or refer to recurrent or persistent mouth lesions.

Product presentation must only refer to mild anxiety.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Homoeopathic product/preparation or medicine (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

Active Ingredients

Aconitum napellus whole plant (Homeopathic)

10 microlitre/g

Equivalent: Total alkaloids (of Aconitum spp.)

0 picogram/g

Actaea spicata rhizome (Homeopathic)

10 microlitre/g

Equivalent: Actaea spicata

1 microgram

Atropa belladonna whole plant (Homeopathic)

10 microlitre/g

Equivalent: Alkaloids calculated as hyoscyamine

0 picogram/g

Equivalent: atropine

0 picogram/g

Citrullus colocynthis fruit flesh (Homeopathic)

10 microlitre/g

colloidal anhydrous silica (Homeopathic)

10 microlitre/g

creosote (Homeopathic)

10 microlitre/g

hahnemann's soluble mercury (Homeopathic)

10 microlitre/g

Matricaria chamomilla whole plant (Homeopathic)

10 microlitre/g

Strychnos nux-vomica seed (Homeopathic)

10 microlitre/g

Equivalent: strychnine (of Strychnos spp.)

0 picogram/g

Other Ingredients (Excipients)

citric acid

dibasic sodium phosphate dihydrate

Flavour

glycerol

hyetellose

potassium sorbate

purified water

© 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 11:03:41 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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