21 CFR Part 348 — External Analgesic Drug Products for Over-the-Counter Human Use

PART 348—EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 57 FR 27656, June 19, 1992, unless otherwise noted. Subpart A—General Provisions § 348.1 Scope. (a) An over-the-counter external analgesic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 348.3 Definitions. As used in this part: (a) Male genital desensitizing drug product. (b) [Reserved] Subpart B—Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient: (a) Male genital desensitizers. (2) Lidocaine in a metered spray with approximately 10 milligrams per spray. (b) [Reserved] Subpart C—Labeling § 348.50 Labeling of external analgesic drug products. (a) Statement of identity. (1) For products containing any ingredient identified in § 348.10(a). (2) [Reserved] (b) Indications. (1) For products containing any ingredient identified in § 348.10(a). (ii) “For temporary male genital desensitization, helping to slow the onset of ejaculation.” (iii) “Helps in temporarily” (select one of the following: “retarding the onset of,” “slowing the onset of,” or “prolonging the time until”) followed by “ejaculation.” (iv) “For reducing oversensitivity in the male in advance of intercourse.” (2) [Reserved] (c) Warnings. (1) For products containing any ingredient identified in § 348.10(a). (ii) “Avoid contact with the eyes.” (iii) “If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.” (2) [Reserved] (d) Directions. (1) For products containing any ingredient identified in § 348.10(a) For products containing benzocaine identified in § 348.10(a)(1). (ii) For products containing lidocaine identified in § 348.10(a)(2). (2) [Reserved] (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.

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