Saline Nasal Spray for Baby

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

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Active ingredient:
Allium cepa,Anemone pulsatilla,calcium sulfide,potassium dichromate,potassium iodide,sodium chloride
Available from:
Brauer Natural Medicine Pty Ltd
Authorization status:
Listed
Authorization number:
351663

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Public Summary

Summary for ARTG Entry:

351663

Baby Saline Nasal Spray

ARTG entry for

Medicine Listed

Sponsor

Brauer Natural Medicine Pty Ltd

Postal Address

PO Box 234, TANUNDA, SA, 5352

Australia

ARTG Start Date

14/12/2020

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 . Baby Saline Nasal Spray

Product Type

Single Medicine Product

Effective Date

14/12/2020

Permitted Indications

Traditionally used in Homoeopathic medicine to unblock/clear nasal passages in infants

Unblock/clear nasal passages in infants

Traditionally used in Homoeopathic medicine to unblock/clear nasal passages

Traditionally used in Homoeopathic medicine to decrease/reduce excess mucous in infants

Indication Requirements

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

Product presentation must not imply or refer to serious forms of respiratory disorders/diseases, such as: asthma, pneumonia, COAD, COPD, influenza.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Contains homoeopathic ingredients.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Spray, nasal

Route of Administration

Nasal

Visual Identification

Active Ingredients

Allium cepa bulb (Homeopathic)

200 microlitre/mL

Anemone pulsatilla whole plant (Homeopathic)

200 microlitre/mL

Public Summary

Page 1 of

Produced at 11.01.2021 at 08:33:13 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

calcium sulfide (Homeopathic)

200 microlitre/mL

potassium dichromate (Homeopathic)

200 microlitre/mL

potassium iodide (Homeopathic)

200 microlitre/mL

sodium chloride

9 mg/mL

Other Ingredients (Excipients)

benzalkonium chloride

dibasic sodium phosphate dihydrate

disodium edetate

monobasic sodium phosphate dihydrate

© 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 08:33:13 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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