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Flanders Buttocks Ointment

This article was originally published in The Tan Sheet

Executive Summary

Diaper rash product will be the topic of an OTC drug "feedback" meeting Nov. 19. FDA told the company in a 1994 letter the product's active ingredient, 6% Peruvian balsam, was lacking a current USP standard ("The Tan Sheet" Nov. 7, 1994, p. 16). The agency also advised the company to conduct safety and efficacy studies for consideration of inclusion of the ointment in the monograph for OTC diaper rash ointments; Peruvian balsam is currently Category III (data insufficient). FDA additionally instructed the company to submit safety and efficacy data on castor oil 11%, which the company maintained was an inactive ingredient. In the December 1992 OTC Final Monograph for External Analgesic Drug Products, the agency concluded external analgesics could not bear claims for diaper rash treatment or prevention
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