HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA on triclosan

This article was originally published in The Rose Sheet

Executive Summary

Agency solicits safety and efficacy data on .3% triclosan as an antigingivitis ingredient in dental pastes and oral rinses in a notice slated to be published in the Federal Register July 6. FDA will review data to determine if ingredients can be generally recognized as safe and effective under the OTC oral health care drug products monograph. Comments will be accepted up to 90 days following publication of the notice. Triclosan review responds to a time and extent application filed by Ciba Specialty Chemicals last November. In the TEA, Ciba stated that 3.5 bil. units of dental paste containing triclosan have been used in 13 selected countries over the past six years (1"The Rose Sheet" Dec. 8, 2003, p. 5). Triclosan currently is marketed in the U.S. as an oral care ingredient through an NDA filed by Colgate-Palmolive...

You may also be interested in...

Triclosan Antigingivitis Effectiveness Data Questioned By P&G, Colgate

Data evaluating the efficacy of triclosan as an antigingivitis ingredient do not support its inclusion as a Category I active in the OTC Antigingivitis/ Antiplaque Monograph, according to the oral care industry's two leading marketers, Procter & Gamble and Colgate-Palmolive


Colgate-Palmolive requests 45 day extension to FDA's deadline for submitting safety and efficacy data on triclosan as an antigingivitis ingredient in dental pastes and oral rinses. Deadline was originally set for Oct. 4, but Colgate requests that date be postponed until Nov. 18 in a Sept. 17 letter to the agency. Additional time will allow Colgate the opportunity to evaluate efficacy data on products formulated with triclosan in the U.S. and abroad in regard to the new time and extent application procedures, Colgate says, noting by extending the deadline, FDA will permit the company to prepare a comprehensive submission. FDA issued a call for data on .3% triclosan in July to determine if the ingredient should be considered safe and effective under the OTC Oral Health Care Products Monograph (1"The Rose Sheet" July 5, 2004, In Brief)...

Triclosan Antigingivitis/Antiplaque Monograph Status Sought By Ciba

Ciba Specialty Chemicals requests that FDA include triclosan in its upcoming OTC monograph for antigingivitis/antiplaque oral care products in a recently-filed application

Related Content




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts