Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter D - Drugs for Human Use |
Part 346 - Anorectal Drug Products for over-the-Counter Human Use |
Subpart B - Active Ingredients |
§ 346.10 - Local anesthetic active ingredients.
Latest version.
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§ 346.10 Local anesthetic active ingredients.
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.