21 C.F.R. § 346.10

Local anesthetic active ingredients.

Last amended: 2016Year: 2026Length: 83 wordsSubsections: 9Official source

Cite as 21 C.F.R. § 346.10 (2026)

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.
21 C.F.R. § 346.10: Local anesthetic active ingredients. | Justis AI