---
kind: "section"
citation: "21 C.F.R. § 346.16"
title: "21"
number: "346.16"
heading: "Analgesic, anesthetic, and antipruritic active ingredients."
url: "https://uscodex.org/cfr/21/346.16"
---

# §346.16. Analgesic, anesthetic, and antipruritic active ingredients.


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

- (a) Camphor 0.1 to 3 percent.
- (b) **Juniper tar 1 to 5 percent.**
- (c) Menthol 0.1 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.