Pt. 348 21 CFR Ch. I (4–1–11 Edition) should be used and any or all of the ad- Subpart C—Labeling ditional indications for sunscreen drug 348.50 Labeling of external analgesic drug products may be used. products. (c) Warnings. The labeling of the AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, product states, under the heading 360, 371. ‘‘Warnings,’’ the warning(s) for each in- gredient in the combination, as estab- SOURCE: 57 FR 27656, June 19, 1992, unless otherwise noted. lished in the warnings section of the applicable OTC drug monographs un- less otherwise stated in this paragraph Subpart A—General Provisions (c). § 348.1 Scope. (1) For combinations containing a skin (a) An over-the-counter external an- protectant and a sunscreen identified in algesic drug product in a form suitable §§ 347.20(d) and 352.20(b). The warnings for topical administration is generally for sunscreen drug products in recognized as safe and effective and is § 352.60(c) of this chapter are used. not misbranded if it meets each condi- (2) [Reserved] tion in this part and each general con- (d) Directions. The labeling of the dition established in § 330.1 of this product states, under the heading ‘‘Di- chapter. rections,’’ directions that conform to (b) References in this part to regu- the directions established for each in- latory sections of the Code of Federal gredient in the directions sections of Regulations are to chapter I of title 21 the applicable OTC drug monographs, unless otherwise noted. unless otherwise stated in this para- § 348.3 Definitions. graph (d). When the time intervals or age limitations for administration of As used in this part: the individual ingredients differ, the (a) Male genital desensitizing drug directions for the combination product product. A drug product applied to the penis to help in temporarily slowing may not contain any dosage that ex- the onset of ejaculation. ceeds those established for any indi- (b) [Reserved] vidual ingredient in the applicable OTC drug monograph(s), and may not pro- vide for use by any age group lower Subpart B—Active Ingredients than the highest minimum age limit § 348.10 Analgesic, anesthetic, and established for any individual ingre- antipruritic active ingredients. dient. The active ingredient of the product (1) For combinations containing a skin consists of any of the following within protectant and a sunscreen identified in the specified concentration established §§ 347.20(d) and 352.20(b). The directions for each ingredient: for sunscreen drug products in (a) Male genital desensitizers. (1) Ben- § 352.60(d) of this chapter are used. zocaine, 3 to 7.5 percent in a water- (2) [Reserved] soluble base. (2) Lidocaine in a metered spray with PART 348—EXTERNAL ANALGESIC approximately 10 milligrams per spray. (b) [Reserved] DRUG PRODUCTS FOR OVER-THE- COUNTER HUMAN USE Subpart C—Labeling Subpart A—General Provisions § 348.50 Labeling of external analgesic drug products. Sec. 348.1 Scope. (a) Statement of identity. The labeling 348.3 Definitions. of the product contains the established name of the drug, if any, and identifies Subpart B—Active Ingredients the product as follows: (1) For products containing any ingre- 348.10 Analgesic, anesthetic, and anti- dient identified in § 348.10(a). ‘‘Male gen- pruritic active ingredients. ital desensitizer.’’ 288 VerDate Mar<15>2010 13:22 May 12, 2011 Jkt 223069 PO 00000 Frm 00298 Fmt 8010 Sfmt 8010 Y:\SGML\223069.XXX 223069 WReier-Aviles on DSKGBLS3C1PROD with CFR.