21 CFR § 346.10 - Local anesthetic active ingredients.

---
identifier: "/us/cfr/t21/s346.10"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 346.10 - Local anesthetic active ingredients."
title_number: 21
title_name: "Food and Drugs"
section_number: "346.10"
section_name: "Local anesthetic 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: "346"
part_name: "ANORECTAL 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: "55 FR 31779, Aug. 3, 1990, unless otherwise noted."
cfr_part: "346"
---


# 346.10 Local anesthetic active ingredients.

The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient:

(a) Benzocaine 5 to 20 percent.

(b) Benzyl alcohol 1 to 4 percent.

(c) Dibucaine 0.25 to 1 percent.

(d) Dibucaine hydrochloride 0.25 to 1 percent.

(e) Dyclonine hydrochloride 0.5 to 1 percent.

(f) Lidocaine 2 to 5 percent.

(g) Pramoxine hydrochloride 1 percent.

(h) Tetracaine 0.5 to 1 percent.

(i) Tetracaine hydrochloride 0.5 to 1 percent.