VICKS VAPORUB EASY APPLICATOR

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

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Active ingredient:
Eucalyptus Oil,menthol
Available from:
Procter & Gamble Australia Pty Ltd
Authorization status:
Listed
Authorization number:
322561

Public Summary

Summary for ARTG Entry:

322561

VICKS VAPORUB EASY APPLICATOR

ARTG entry for

Medicine Listed

Sponsor

Procter & Gamble Australia Pty Ltd

Postal Address

Level 4/ 1 Innovation Road,MACQUARIE PARK, NSW, 2113

Australia

ARTG Start Date

2/09/2019

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. VICKS VAPORUB EASY APPLICATOR

Product Type

Single Medicine Product

Effective date

2/09/2019

Permitted Indications

Decrease/reduce/relieve muscle pain/ache/soreness in adults

Decrease/reduce/relieve muscle pain/ache/soreness in children over 2 years of age

Decrease/reduce/relieve headache symptoms in adults

Decrease/reduce/relieve headache symptoms in children over 2 years of age

Decongestant/relieve nasal congestion in adults

Decongestant/relieve nasal congestion in children over 2 years of age

Decrease/reduce/relieve symptoms of common cold in children over 2 years of age

Linked indication - Decongestant/relieve nasal congestion

Linked indication - Decrease/reduce/relieve muscle pain/ache/soreness

Linked indication - Decrease/reduce/relieve cough

Decrease/reduce/relieve symptoms of common cold in adults

Decrease/reduce/relieve symptoms of common cold in children over 2 years of age

Decrease/reduce/relieve symptoms of common cold in adults

Linked indication - Decrease/reduce/relieve cough

Linked indication - Decongestant/relieve nasal congestion

Linked indication - Decrease/reduce/relieve muscle pain/ache/soreness

Decrease/reduce/relieve cough in children over 2 years of age

Decrease/reduce/relieve cough in adults

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.

Standard Indications

No Standard Indications included on Record

Public Summary

Page 1 of

Produced at 29.09.2019 at 05:48:40 AEST

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

Specific Indications

Warnings

No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Ointment

Route of Administration

Topical

Visual Identification

Active Ingredients

Eucalyptus Oil

15 mg/g

menthol

27.5 mg/g

© 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 29.09.2019 at 05:48:40 AEST

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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