---
kind: "section"
citation: "21 C.F.R. § 346.10"
title: "21"
number: "346.10"
heading: "Local anesthetic active ingredients."
url: "https://uscodex.org/cfr/21/346.10"
---

# §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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.