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OTC diaper rash products

This article was originally published in The Tan Sheet

Executive Summary

Compliance bulletin issued to the field on May 21 notes that "the use of any active external analgesic ingredient and/or topical antifungal ingredient in a product offered to treat and/or prevent diaper rash introduced . . . into interstate commerce" after June 17 without an approved NDA will be in violation of the FD&C Act. The final rules for external analgesics and topical antifungals used for diaper rash were published Dec. 18, 1992 and go into effect on June 18. The bulletin lists several products for diaper rash, including Fisons' Caldesene Medicated Powder and Ointment, Fleming's Impregon, Sween's Sween Cream, Macsil's Balmex Baby Powder, and Innotek's Bottom Better.

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