Regulations last checked for updates: May 23, 2025

Title 21 - Food and Drugs last revised: May 19, 2025
§ 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.

source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.
cite as: 21 CFR 346.16