21 CFR § 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

---
identifier: "/us/cfr/t21/s348.10"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 348.10 - Analgesic, anesthetic, and antipruritic active ingredients."
title_number: 21
title_name: "Food and Drugs"
section_number: "348.10"
section_name: "Analgesic, anesthetic, and antipruritic active ingredients."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "348"
part_name: "EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "57 FR 27656, June 19, 1992, unless otherwise noted."
cfr_part: "348"
---


# 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]