GroundRules
21 CFR 348.10: Analgesic, anesthetic, and antipruritic active ingredients.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 348—EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart B—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]
Collected 2026-08-27T02:24:47Z. Source file · JSON