§346.10. Local anesthetic active ingredients.
21 C.F.R. § 346.10
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:
Benzocaine 5 to 20 percent.
Benzyl alcohol 1 to 4 percent.
Dibucaine 0.25 to 1 percent.
Dibucaine hydrochloride 0.25 to 1 percent.
Dyclonine hydrochloride 0.5 to 1 percent.
Lidocaine 2 to 5 percent.
Pramoxine hydrochloride 1 percent.
Tetracaine 0.5 to 1 percent.
Tetracaine hydrochloride 0.5 to 1 percent.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source
Source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.