FDA WARNING_LETTER - Dr G H Tichenor Antiseptic Company - August 24, 2010
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On August 24, 2010, an FDA inspection of Dr. G.H. Tichenor Antiseptic Co.'s facility revealed that three products—"DR. TICHENOR’S ANTISEPTIC GEL," "Bruise Relief," and "DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic"—are unapproved new drugs and misbranded.
"DR. TICHENOR’S ANTISEPTIC GEL" is deemed a new drug because its formulation (Alcohol 70%, Peppermint Oil 3%) and claims ("KILLS STAPH & MRSA," insect bite relief) do not comply with the OTC Skin Protectant Drug Products monograph (21 CFR 347) or any relevant Tentative Final Monographs (TFMs) for healthcare antiseptics, first-aid antiseptics, or external analgesics. Peppermint Oil and Alcohol 70% are not recognized skin protectant active ingredients, and the four-way combination of uses is not permitted.
"Bruise Relief" is an unapproved new drug because there is insufficient evidence of its general recognition as safe and effective for claims like reducing bruising, dark circles, and skin discolorations, and it does not qualify for the OTC Drug Review.
"DR. TICHENOR’S Peppermint Mouthwash Concentrate & First Aid Antiseptic" (Alcohol 70%, Peppermint
ID · f35ea137-a2ef-430d-86af-609fb1b522fc
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