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21 C.F.R. § 346.10   Local anesthetic active ingredients.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients

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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.

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