IE: Breathe Roll-on

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

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Active ingredient:
Eucalyptus globulus,Mentha arvensis,Pinus sylvestris
Available from:
Heritage Brands Ltd
INN (International Name):
Eucalyptus globulus,Mentha arvensis,Pinus sylvestris
Authorization status:
Listed
Authorization number:
292509

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Public Summary

Summary for ARTG Entry:

292509

IE: Breathe Roll-on

ARTG entry for

Medicine Listed

Sponsor

Heritage Brands Ltd

Postal Address

PO Box 1435,CLAYTON SOUTH, VIC, 3169

Australia

ARTG Start Date

7/08/2017

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. IE: Breathe Roll-on

Product Type

Single Medicine Product

Effective date

7/08/2017

Warnings

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

Keep out of reach of children (or words to that effect).

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

If symptoms persist, seek the advice of a healthcare professional.

If coughing persists consult your doctor (or a healthcare professional) (or words to that effect).

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

Standard Indications

Temporary relief of cough due to bronchial irritation. [Warnings COU1 and COU2 required]

For relief of mucous congestion.[Warnings S and COLD required]

For the symptomatic relief of sinusitis. [Warning S required]

Relief of sinus pain. [Warning S required]

Helps fight mild upper respiratory complaints. [Warnings S and COLD required]

Relief of the symptoms of hayfever. [Warning S required]

May reduce the severity of colds. [Warning COLD required]

May help reduce the severity of the symptoms of colds. ]Warnings S and COLD required]

Relief of the symptoms of colds. [Warnings S and COLD required]

Temporary relief of bronchial cough by soothing bronchial airways. [Warnings COU1 and COU2 required]

Temporary relief of cough due to bronchial congestion. [Warnings COU1 and COU2 required]

Relief of the cough of bronchitis. (or) Relief of bronchial cough. [Warnings COU1 and COU2 required]

Relief of sinusitis. [Warning S required]

Relief of symptoms of mild upper respiratory infections. [Warnings S and COLD required]

Relief of mucous congestion. [Warnings S and COLD required]

Temporary relief of the cough of bronchitis. (or) Temporary relief of bronchial cough. [Warnings S and COU1 required]

Temporary relief of headaches. [Warning S required]

Public Summary

Page 1 of

Produced at 24.11.2017 at 07:04:35 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

For the symptomatic relief of tension headache. [Warning S required]

Specific Indications

Each of the standard indications as well as the indications below are to be prefaced by the words(or words to the effect of): The essential oils in this

blend have been used traditionally in aromatherapy for:-

or Each of the recommended uses stated is based on accumulated knowledge of the way these oils have been used in traditional aromatherapy.

May Assist in the management of mild upper respiratory tract infections.

Relief of symptoms/management of symptoms of mild migraine and mild neuralgia.

Uplifting, rejuvenating, refreshing, lifts mood

Decongestant ± helps clear nasal passages

Expectorant ± helps loosen phlegm

-assist in the management of symptoms associated with sinusitus

May Assist in the management of mild upper respiratory tract infections

Assist in the management of cold & flu symptoms

helps with management of fever, induces sweating

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Essential Oil

Route of Administration

Inhalation

Topical

Visual Identification

Active Ingredients

Eucalyptus globulus

17.5 microlitre/mL

Mentha arvensis

26.25 microlitre/mL

Pinus sylvestris

26.25 microlitre/mL

© 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 24.11.2017 at 07:04:35 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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