[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR346.10]

[Page 261-262]
 
                        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 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.

[[Page 262]]

    (i) Tetracaine hydrochloride 0.5 to 1 percent.