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

UsernamePublicRestriction
UsernamePublicRestriction

In Brief: OTC anticaries final monograph

This article was originally published in The Rose Sheet

Executive Summary

OTC anticaries final monograph: Final regulation published in Oct. 6 Federal Register lists three ingredients that meet monograph conditions: sodium fluoride, sodium monofluorophosphate and stannous fluoride. In July, Procter & Gamble launched Crest Gum Care with stannous flouride for which it filed an NDA ("The Rose Sheet" July 31, p. 1). The final monograph also lists the sodium monofluorophosphate limit at 1,500 ppm, the amount included in Chese-Pond's Extra Strength Aim. FDA pointed to two clinical studies in making its limitation determination. In the TFM, the agency deemed the 1,500 ppm theoretical total fluorine limit safe but stated that general recognition of its effectiveness must be based on adequate medical and scientific data...
Advertisement
Advertisement
UsernamePublicRestriction

Register

RS002087

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

Cancel