Bosisto's Eucalyptus Spray

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

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Active ingredient:
Eucalyptus Oil
Available from:
Felton Grimwade & Bosisto's Pty Ltd
Authorization status:
Listed
Authorization number:
349597

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Public Summary

Summary for ARTG Entry:

349597

Bosisto's Eucalyptus Spray

ARTG entry for

Medicine Listed

Sponsor

Felton Grimwade & Bosisto's Pty Ltd

Postal Address

PO Box 74, OAKLEIGH SOUTH, VIC, 3167

Australia

ARTG Start Date

25/11/2020

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 . Bosisto's Eucalyptus Spray

Product Type

Single Medicine Product

Effective Date

25/11/2020

Permitted Indications

Decrease/reduce/relieve mild rheumatic aches and pains

Decrease/reduce/relieve muscle pain/ache/soreness

Decongestant/relieve nasal congestion

Decrease/reduce/relieve symptoms of common colds and flu

Antiseptic for minor cuts and abrasions

Decrease/reduce/relieve symptoms of insect bite/sting

Indication Requirements

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

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

Product presentation must not imply or refer to serious infections.

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

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

Product presentation must only refer to mild rheumatic aches/pains.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Contains ethanol. (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).

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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 11.01.2021 at 10:06:54 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

1 . Formulation 1

Dosage Form

Spray, pressurised

Route of Administration

Topical

Inhalation

Visual Identification

Active Ingredients

Eucalyptus Oil

200 mg/g

Other Ingredients (Excipients)

butane

ethanol absolute

propane

© 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 10:06:54 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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