OTC MALE DESENSITIZING PRODUCTS CONTAINING LIDOCAINE OR BENZOCAINE
OTC MALE DESENSITIZING PRODUCTS CONTAINING LIDOCAINE OR BENZOCAINE should not be required to carry a label warning concerning possible adverse effects on sperm and fertility, FDA said in a proposed rule for the OTC product class published in the Oct. 2 Federal Register. "The agency is aware of the ]OTC Miscellaneous External[ Panel's concern about the effect of benzocaine and lidocaine on sperm and the ovum (female egg). Although the Panel's proposed warning statement: 'The effect of this product on sperm and fertility has not been determined,' is intended to be informative, the agency believes that the warning would not achieve any useful purpose and may even be confusing to consumers," FDA said. FDA explained that "both benzocaine and lidocaine have a long history of topical use with relatively few side effects reported." The agency's Topical Analgesic Panel found the ingredients safe for use on the skin, mucous membranes and internally, FDA said, while the OTC Contraceptives and Vaginal Products Panel also found the drugs safe for intravaginal treatment of irritation. "Based on the many years of extensive marketing experience of products containing these ingredients, the recommendations of other advisory panels, and the lack of any data on adverse effects of these drugs on sperm and the ovum, the agency concludes that there is insufficient basis for the warning and is not including it in this tentative final monograph." The agency proposed only benzocaine (3-7.5% in water soluble base) and lidocaine (in a metered spray with approximately 10 mg/spray) for classification as Category I ingredients. FDA concurred with the panel's proposed classification in Category II of benzyl alcohol and ephedrine HCl, and placed camphorated metacresol, which was not classified by the panel, in Category II as well. The proposed Category I indication, FDA said, is: "Aids in the prevention of premature ejaculation." FDA also listed five optional statements which it said were appropriate, adding that other "truthful and nonmisleading statements, describing only the indications for use that have been established and listed ]in the proposed rule[ may also be used."
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