Final Monograph Released for Skin Protectant Drug Products for OTC Use

The FDA released its final monograph for skin protectant drug products for OTC human use to be effective June 4, 2004. The FDA added allantoin, live yeast cell derivative (LYCD) and zinc acetate to its Category III based on lack of evidence of effectiveness (43 FR 34628 at 34644 through 34647). The FDA is also deleting "sunburn" from the indications for skin protectants. In a previous recommendation, the FDA approved a shortened "drug" claim that stated: "For the temporary protection of minor cuts, scrapes, burns, and sunburn" (FR 6820 at 6832). Concerns that skin protectants such as petrolatum may be applied inappropriately to burns and sunburns that have just occurred prompted this action along with evidence that skin protectants do not prevent sunburn. Using skin protectants for symptoms of dryness retains approval with the recommendation that the ingredients allantoin, cocoa butter, dimethicone, glycerin, petrolatum, and shark liver oil be included in the monograph as active ingredients for symptoms of dryness. Manufacturers can no longer include the phrase "to allow healing to begin". The FDA will now also require a separate listing of the active drug ingredients and the cosmetic ingredients where a cosmetic product is also an OTC drug product. Thus manufacturers are not allowed to commingle drug and cosmetic claims within this specific area of labeling. Fed Regist 2003 June 4;68(107):33362-33381. For more information go to http://www.fda.gov or http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2003&mn=6&dy=4 Return to Top