Skin Protectant Rule Amended To Include Prevention, Chafing Indications
This article was originally published in The Rose Sheet
Executive Summary
FDA will permit optional labeling language for OTC skin protectant drug products to include the indications "helps prevent" and "chafed" under a technical amendment to the final monograph, published in the Federal Register Dec. 9
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FDA will permit optional labeling language for OTC skin protectant drug products to include the indications "helps prevent" and "chafed" under a technical amendment to the final monograph, published in the Federal Register Dec. 9. In the final rule, labeling for both skin and lip protectant products was limited to the phrases "temporarily protects" and "helps relieve" chapped or cracked skin and lips. The technical amendment permits optional use of "helps prevent" and adds "chafed" to the description of skin conditions. The amendment directly responds to a July 7 petition from the Cosmetic, Toiletry and Fragrance Association requesting reinstatement of the optional indications (1 (Also see "Skin Protectant Chafing Indications Should Be Included In Final Rule - CTFA" - HBW Insight, 21 Jul, 2003.), p. 8). The terms were included in the tentative final monograph, published in 1983, but were eliminated in the June final rule (2 (Also see "Skin Protectant Chafing Indications Should Be Included In Final Rule - CTFA" - HBW Insight, 21 Jul, 2003.), p. 3). FDA also is amending indications for products formulated and labeled as lip protectants but containing only cocoa butter, petrolatum, or white petrolatum alone or in combination to conform to lip protectant labeling. The indication, "use helps protect chapped lips" now may also include optional terms "prevent" and "relieve." The terms also may be added to the indication, "use helps protect minor cuts and burns" and/or "chapped skin." In addition, the agency plans to add "prevents" to labeling language for combination products containing skin protectant and sunscreen active ingredients, the agency states. However, "because the final monograph for OTC sunscreen drug products...is currently stayed, FDA intends to propose this revision in an amendment of that monograph in a future issue of the Federal Register," the agency says. The skin protectant final rule becomes effective June 4 for most manufacturers, but products with annual sales under $25,000 have until June 6, 2005 to comply. Comments are due Feb. 9. |