Saline Ultra Nasal Spray

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

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Active ingredient:
Eucalyptus Oil,Peppermint Oil,sodium chloride
Available from:
Brauer Natural Medicine Pty Ltd
Authorization status:
Listed
Authorization number:
349939

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Public Summary

Summary for ARTG Entry:

349939

Saline Ultra 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

27/11/2020

Product Category

Medicine

Status

Active

Approval Area

Listed Medicines

Products

1 . Saline Ultra Nasal Spray

Product Type

Single Medicine Product

Effective Date

27/11/2020

Permitted Indications

Decongestant/relieve nasal congestion

Unblock/clear nasal passages

Traditionally used in Aromatherapy to decrease/reduce/relieve symptoms of common cold

Traditionally used in Aromatherapy to decrease/reduce/relieve cough

Indication Requirements

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

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

Label statement: Adults only, OR Not to be used in children under 2 years of age without medical advice (or words to that effect).

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

No Warnings included on Record

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

Eucalyptus Oil

1.5 mg/mL

Peppermint Oil

1.5 mg/mL

sodium chloride

9 mg/mL

Other Ingredients (Excipients)

benzalkonium chloride

dibasic sodium phosphate dihydrate

disodium edetate

monobasic sodium phosphate dihydrate

purified water

Public Summary

Page 1 of

Produced at 11.01.2021 at 09:55:42 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

© 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 09:55:42 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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