21 CFR § 348.10 External Analgesic Drug Products for Over-the-Counter Human Use

§ 348.10 Analgesic, anesthetic, and antipruritic active ingredients.

Current through Sep 8, 2026 · Read all of Part 348

The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient:

(a) Male genital desensitizers. (1) Benzocaine, 3 to 7.5 percent in a water-soluble base.

(2) Lidocaine in a metered spray with approximately 10 milligrams per spray.

(b) [Reserved]

← § 348.3 Definitions.§ 348.50 Labeling of external analgesic drug products. →