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OTC ORAL WOUND CLEANSERS WILL BE COVERED BY FDA

Executive Summary

OTC ORAL WOUND CLEANSERS WILL BE COVERED BY FDA in an upcoming tentative final monograph for oral anesthetic/analgesics, astringents, debriding agents, oral wound cleansers, and demulcent drug products. Carbamide peroxide, hydrogen peroxide, and sodium perborate monohydrate will be treated as debriding agents and oral wound cleansers, FDA said in a July 18 Federal Register notice regarding oral wound healing agents. The decision to combine debriding agents and oral wound cleansers into one therapeutic class followed from industry comments on the wound healing monograph. The comments "pointed out the similarities between oral wound cleansers and debriding agents and requested that the labeling for these ingredients be consistent between the two rulemakings," the agency explained. FDA further noted that combination products containing an oral wound cleanser and an antiseptic will be covered in another monograph. In the July 18 Federal Register notice, the agency said no information on efficacy was submitted to support continued use of four ingredient groups as oral wound healing agents. "Allantoin, carbamide peroxide in anhydrous glycerin, water soluble chlorophyllins, and hydrogen peroxide in aqueous solution are safe for use as oral wound healing, agents," the agency noted, "but there are inadequate data to establish general recognition of the effectiveness of these ingredients as oral wound healing agents." FDA defined oral wound healing agents as "aids in the healing of minor oral wounds by means other than cleansing and irrigating, or by serving as a protectant." The Federal Register notice sets a deadline of July 18, 1987 to relabel or reformulate products to remove the oral wound healing claim. "The agency is aware," FDA said, "that products containing some of the above ingredients have been on the OTC market and that these OTC drug products have had multiple claims. Purported oral wound healing agents must be removed from these OTC drug products or the product must be relabeled to exclude oral wound healing claims by the effective date of this final rule unless the product has an approved NDA." Although the OTC rule appeared in the July 18 Federal Register, it was approved for publication by FDA Com. Young and HHS Secty. Bowen on March 5. The four-month delay to Federal Register publication for a minor OTC rule exemplifies the wrapping up difficulties for the OTC Review.
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