Diphenhydramine topicals warning against use on "large areas" of body endorsed by NDMA.
This article was originally published in The Tan Sheet
Executive Summary
DIPHENHYDRAMINE WARNING ON USE OVER "LARGE AREAS" OF BODY ENDORSED BY NDMA for topical OTC products in Nov. 25 comments to FDA. The Nonprescription Drug Manufacturers Association also endorses a label warning against use with other products containing diphenhydramine. The letter responds to FDA's advance notice of proposed rulemaking for OTC diphenhydramine-containing products, published Aug. 29, which would require topical diphenhydramine products to carry warnings against use in cases of chicken pox, poison ivy or sunburn, on large areas of the body, on blistered or oozing skin, more often than directed or with any other diphenhydramine-containing drug, including those taken orally ("The Tan Sheet" Sept. 1, p. 4).
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