Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter D - DRUGS FOR HUMAN USEPart 348 - EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B - ACTIVE INGREDIENTS
Section 348.10 - Analgesic, anesthetic, and antipruritic active ingredients

21 C.F.R. § 348.10

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Current through November 30, 2024
Section 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]

21 C.F.R. § 348.10