Docstoc

ARGOM - coal tar preparations - prior to 13 Feb 2004

Document Sample
ARGOM - coal tar preparations - prior to 13 Feb 2004 Powered By Docstoc
					This part of Chapter 9 of the Australian Regulatory Guidelines for OTC Medicines (ARGOM)
was replaced on 13 February 2004. The information below is provided for historical reference
only. Please refer to the ARGOM for the most current information.


Coal tar preparations
All coal tar preparations contain mutagens and are potentially carcinogenic. Justification for
the inclusion of coal tar in terms of benefit versus risk should be provided. Indications for use
in minor conditions (eg. napkin rash) will not be accepted.

Because of the potential for increased absorption associated with the use of coal tar under
occlusive dressings, a warning should be included on the product’s label (and Consumer
Medicine Information (CMI) and Product Information (PI) where these are included), such as:

·   Not to be used under occlusion except on medical advice.

The use of a light bandage to prevent staining of clothes is acceptable.




                  Address: PO Box 100 Woden ACT 2606 Website: www.tga.gov.au
                Telephone: 02 6232 8444 Facsimile: 02 6232 8605 ABN 40 939 406 804

				
DOCUMENT INFO
Shared By:
Categories:
Stats:
views:7
posted:4/27/2010
language:English
pages:1
Description: ARGOM - coal tar preparations - prior to 13 Feb 2004