CANESTEN PLUS CLOTRIMAZOLE AND HYDROCORTISONE CREAM tube (new formulation)

Main information

  • Trade name:
  • CANESTEN PLUS CLOTRIMAZOLE AND HYDROCORTISONE CREAM tube (new formulation)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CANESTEN PLUS CLOTRIMAZOLE AND HYDROCORTISONE CREAM tube (new formulation)
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 192113
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

192113

CANESTEN PLUS CLOTRIMAZOLE AND HYDROCORTISONE CREAM tube (new formulation)

ARTG entry for

Medicine Registered

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072

Australia

ARTG Start Date

15/11/2011

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Conditions

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

1. CANESTEN PLUS CLOTRIMAZOLE AND HYDROCORTISONE CREAM tube (new formulation)

Product Type

Single Medicine Product

Effective date

1/03/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For dermatophyte and yeast infections of the skin when inflammation is prominent. This includes conditions such as fungal infected intertrigo.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Tube

Epoxy-coated Al

36 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

15 g

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Cream

Route of Administration

Topical

Visual Identification

White to slightly yellowish cream

Active Ingredients

Clotrimazole

10 mg/g

Hydrocortisone acetate

11.2 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 1 of

Produced at 28.11.2017 at 09:29:25 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