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Jergens Anti-Bacterial lotion

This article was originally published in The Tan Sheet

Executive Summary

Prophylactic claims for product draw April 22 warning letter from FDA. Claims include "Your skin needs daily protection from...the bacteria and germs you encounter every day and...bonds to skin for germ protection." The agency states that "representatives for prophylactic antimicrobial barrier use...are not described in any of the rulemakings being considered under the [OTC] Review. Further, we are not aware of any substantial scientific evidence that Jergens Anti-Bacterial Antiseptic Lotion is generally recognized among scientific experts as safe and effective for these uses, and this product has not been marketed for a material time and to a material extent." As a result, the product, which contains benzalkonium chloride, is considered an unapproved new drug, according to FDA. Andrew Jergens is preparing a response. The agency sent a similar letter to Bristol-Myers Squibb in May 1998 for its Keri Anti-Bacterial Lotion ("The Tan Sheet" June 15, 1998, p. 3)
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