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Executive Summary

OTC TOPICAL ANTIMICROBIALS TFM SUGGESTS PHENOL SWITCH TO CATEGORY I status along with three other ingredients -- camphorated phenol, iodine and povidine-iodine -- previously considered Category III. The tentative final monograph (TFM) on OTC topical antimicrobials, published in the July 22 Federal Register, is an amendment to the previous TFM, which was published on Jan. 6, 1978, and continues the rulemaking process to establish a monograph for OTC topical antimicrobial drug products that began on Sept. 13, 1974. The four ingredients/combinations are also being put into a consolidated category which the TFM proposes to call "first aid antiseptic drug products." The group comprises the previous categories of skin antiseptics, skin wound cleansers and skin wound protectants. Also elevated to Category I are several OTC antimicrobial ingredients that were not reviewed in the 1978 TFM: hydrogen peroxide, camphorated metacresol, and a combination product made of eucalyptol (0.091%), menthol (0.042%), methyl salicylate (0.055%) and thymol (0.063%), in 26.9% alcohol. The TFM proposes to ban mercury compounds by listing the active ingredient as Category II, concurring with an earlier OTC Review panel's recommendation. Products containing mercury compounds, such as mercurochrome or merthiolate, would either have to be reformulated or be removed from the market once the final rule went into effect. Noting that "(BRACKET)t(BRACKET)his antimicrobial rulemaking is broad in scope," FDA states in the TFM that it will discuss only the newly defined "first aid antiseptics" and will publish in a separate TFM rules concerning daily use topical antimicrobials and products "generally intended for use by health professionals," such as healthcare personnel handwashes, patient preoperative skin preparations and surgical hand scrubs. The notice specifies several claims allowed for first aid antiseptics under the TFM, including wording that indicates the product can "prevent," "guard against," or "protect against," (or "decrease" or "reduce" the "risk of" or "the chance of") "infection," "bacterial contamination," or "skin infection" in "minor cuts, scrapes, and burns." The TFM defines a first aid antiseptic as "an antiseptic-containing drug product applied topically to the skin to help prevent infection in minor cuts, scrapes, and burns." The TFM allows the combination of any single first aid antiseptic ingredient with any single analgesic active ingredient or skin protectant active ingredient identified in a specified section of the TFM. Antiseptic-analgesic combinations may be indicated for "first aid for the temporary relief" of "pain," "discomfort," "pain or discomfort," or "pain and itching" in "minor cuts, scrapes, and burns." Antiseptic-skin protectant combinations may be indicated for "first aid for the temporary protection of minor cuts, scrapes, and burns." The TFM also declares that "(BRACKET)s(BRACKET)oaps containing antimicrobial ingredients are considered cosmetics when deodorancy and other cosmetic claims are the only claims made for the products" and are not included in the TFM. Antimicrobial soaps labeled for other uses "will be discussed in the segment of this rulemaking dealing with uses other than first aid in a future issue of the Federal Register."

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