Public Summary: 1 - Chlorhexidine 0.5% in Alcohol 70% Solution Bottle

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Public Summary

Summary for ARTG Entry: 11339 CHLORHEXIDINE 0.5% IN ALCOHOL 70% SOLUTION bottle

ARTG entry for Medicine Registered

Sponsor Pfizer Australia Pty Ltd


Postal Address Level 17 151 Clarence Street, Sydney, NSW, 2000
Australia
ARTG Start Date 13/08/1991
Product Category Medicine
Status Active
Approval Area Non-Prescription Medicines

Conditions

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Applying to Therapeutic Goods
Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods Under
Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered or
Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

Public Summary
1 . CHLORHEXIDINE 0.5% IN ALCOHOL 70% SOLUTION bottle
Product Type Single Medicine Product Effective Date 12/03/2020

Permitted Indications
No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For topical antisepsis.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type Material Life Time Temperature Closure Conditions


Bottle HDPE 2 Years Store below 25 Not recorded Protect from Light
degrees Celsius

Pack Size/Poison information

Pack Size Poison Schedule


100mL Not scheduled. Not considered by committee

Components
1.

Dosage Form Application


Route of Administration Topical
Visual Identification Pink solution

Active Ingredients

chlorhexidine gluconate 5 mg/mL


ethanol 736 microlitre/mL

Page 1 of 2 Produced at 16.08.2020 at 05:52:53 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
Other Ingredients (Excipients)

carmoisine
water for injections

© 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 2 Produced at 16.08.2020 at 05:52:53 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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