[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR346.10]

[Page 269-270]
 
                        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 
 
                      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 270]]

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.