Keri Anti-Bacterial Hand Lotion prophylaxis claims cited in FDA warning letter.
This article was originally published in The Tan Sheet
Executive Summary
BRISTOL KERI ANTI-BACTERIAL LOTION PROPHYLACTIC CLAIMS DRAW WARNING LETTER from FDA citing the antibacterial hand lotion as an unapproved new drug that may not be marketed in the U.S. without an approved NDA. Preventative indications for Bristol- Myers Squibb's Keri Anti-Bacterial Hand Lotion "do not qualify for evaluation under the ongoing OTC drug review being conducted by the FDA," the May 8 warning letter states. According to the agency, the product is intended for "repeated use on the hands by the general public and by health care professionals as an antiseptic/moisturizer and to remain on the skin to provide hours of continuous antimicrobial effectiveness against pathogenic microorganisms."
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