This article was originally published in The Tan Sheet
Draft report on "OTC Drug Products for the Reduction or Prevention of Dental Plaque and Gingivitis" available for public review and comment in FDA docket 81N-033P. The report contains the tentative conclusions of FDA's Dental Plaque Subcommittee, a subgroup of NDAC. The document "is not the final adopted report of the Subcommittee," OTC Division Acting Director Debra Bowen, MD, notes in a cover letter, adding that the report may be revised at the group's Dec. 2-3 meeting. At the subcommittee's last meeting, the group endorsed an antiplaque claim for stannous fluoride and determined final formulation testing requirements for monograph ingredients ("The Tan Sheet" Nov. 2, pp. 6-7). Ingredients the Subcommittee recommends for Category I inclusion in the monograph include cetylpyridinium chloride for use in mouthrinse formulations, stannous fluoride as a dentifrice, and a fixed combination of essential oils (thymol, menthol, eucalyptol and methyl salicylate)
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