Code of Federal Regulations · Section
§ 346.10 — Local Anesthetic Active Ingredients
21 C.F.R. § 346.10
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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.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321