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Executive Summary

OTC TOPICAL ANTIFUNGAL DRUG DIAPER RASH CLAIMS MUST BE ELIMINATED by June 18, 1993, FDA said in a Dec. 18 Federal Register notice. In a final rule on diaper rash claims for over- the-counter topical antifungal drug products, the agency declared that any OTC topical antifungal used in the "treatment and/or prevention of diaper rash is not generally recognized as safe and effective and is misbranded." Therefore, companies marketing such products must cease distribution or remove the diaper rash claims within six months. FDA emphasized that "manufacturers are urged to comply voluntarily with this final rule at the earliest possible date." In a separate Dec. 18 Federal Register notice, FDA determined that diaper rash claims should be removed from all OTC external analgesic drug products. Like topical antifungal treatments of diaper rash, the agency decided that external analgesics are not generally recognized as safe and effective for the treatment of diaper rash and should be taken off the market by June 18, 1993. In June 1990, FDA published a proposed rule for diaper rash products culled from four separate tentative final monographs: external analgesics, topical antifungals, topical antimicrobials and skin protectants. In the proposal, FDA did not list any antifungal or external analgesic ingredients as Category I (safe and effective) for the diaper rash claim ("The Pink Sheet" June 25, 1990, p. 21). Catch-all lists of OTC ingredients published in November 1990 and August 1992 also proposed the withdrawal of diaper rash ingredients not considered Category I ("The Pink Sheet" Aug. 31, p. 4). Upcoming Federal Register notices will include a final rule for OTC skin protectant drug products for the treatment of diaper rash, a final monograph on external analgesics and a final monograph for topical antifungals, FDA said. In another Dec. 18 Federal Register notice, the agency established that yellow mercuric oxide is not recognized as safe and effective as an OTC ophthalmic anti-infective. Moreover, FDA declared that "no active ingredient has been determined to be generally recognized as safe and effective for" use as an ophthalmic anti-infective drug product, thereby excluding anti-infective ingredients from the monograph for OTC ophthalmic drug products. The agency gave firms until June 18, 1993 to remove OTC drugs products containing ophthalmic anti- infective active ingredients from the market. The Dec. 18 notice responds to a request by Del Labs to include yellow mercuric oxide in the final monograph for OTC ophthalmic drug products. Del's Commerce Drug Co. markets Stye (YMO 1%) ointment for the treatment of blepharitis and proposed to study Stye for that indication at a March OTC "feedback" meeting with FDA ("The Pink Sheet" April 13, T&G-16). However, FDA stated in the notice that "data are inadequate to demonstrate that yellow mercuric oxide is safe and effective for the treatment of styes and blepharitis."

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