[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: 21CFR346.14]

[Page 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.  346.14  Protectant active ingredients.

    (a) The following active ingredients may be used as the sole 
protectant active ingredient in a product if the ingredient as 
identified constitutes 50 percent or more by weight of the final 
product. In addition, the following active ingredients may be used in 
concentrations of less than 50 percent by weight only when used in 
combinations in accordance with Sec.  346.22 (a), (b), or (n).
    (1) Aluminum hydroxide gel.
    (2) Cocoa butter.
    (3) Glycerin in a 20- to 45-percent (weight/weight) aqueous solution 
so that the final product contains not less than 10 and not more than 45 
percent glycerin (weight/weight). Any combination product containing 
glycerin must contain at least this minimum amount of glycerin.
    (4) Hard fat.
    (5) Kaolin.
    (6) Lanolin.
    (7) Mineral oil.
    (8) Petrolatum.
    (9) Topical starch.
    (10) White petrolatum.
    (b) The following active ingredients may not be used as a sole 
protectant ingredient but may be used in combination with one, two, or 
three other protectant active ingredients in accordance with Sec.  
346.22 (a), (b), (n), and (o) and with the following limitations:
    (1) Calamine not to exceed 25 percent by weight per dosage unit 
(based on the zinc oxide content of calamine).
    (2) Cod liver oil, provided that the product is labeled so that the 
amount of the product that is used in a 24-hour period represents a 
quantity that provides 10,000 U.S.P. units of vitamin A and 400 U.S.P. 
units of cholecalciferol.
    (3) Shark liver oil, provided that the product is labeled so that 
the amount of the product that is used in a 24-hour period represents a 
quantity that provides 10,000 U.S.P. units of vitamin A and 400 U.S.P. 
units of cholecalciferol.
    (4) Zinc oxide not to exceed 25 percent by weight per dosage unit.