CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 348—EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > SUBPART B—Active Ingredients (§348.10 to §348.10) > 348.10—Analgesic, anesthetic, and antipruritic 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. (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]