[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR346.10]

[Page 262-263]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 346--ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                      Subpart B--Active Ingredients
 
Sec. 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

[[Page 263]]

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.