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OTC wart removers

This article was originally published in The Tan Sheet

Executive Summary

FDA proposes a change in monograph labeling for OTC wart remover products containing 15% salicylic acid in a karaya gum, glycol plaster vehicle to include new directions for use. In a proposed rule appearing in the Jan. 28 Federal Register, FDA adds directions for use of an emery file and advises consumers to "apply a drop of warm water to the wart" prior to applying the medicated plaster. FDA noted that the only company currently marketing such a product has added these directions to product labeling. The agency said it is proposing the labeling change in order to avoid "consumer confusion" if other products, such as private labels, are using the current final monograph directions for use

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