[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR346.22]

[Page 271]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 346_ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER 
HUMAN USE--Table of Contents
 
                      Subpart B_Active Ingredients
 
Sec. 346.22  Permitted combinations of anorectal active ingredients.

    (a) Any two, three, or four protectants identified in Sec. 
346.14(a) may be combined, except aluminum hydroxide gel in Sec. 
346.14(a)(1) and kaolin in Sec. 346.14(a)(5) may not be combined with 
any ingredient in Sec. 346.14(a) (2), (4), (6), (7), (8) and (10), and 
(b) (2) and (3), provided that the combined percentage by weight of all 
protectants in the combination is at least 50 percent of the final 
product (e.g., 1 gram of a 2-gram dosage unit). Any protectant 
ingredient included in the combination must be present at a level that 
contributes at least 12.5 percent by weight (e.g., 0.25 gram of a 2-gram 
dosage unit), except cod liver oil and shark liver oil. If an ingredient 
in Sec. 346.14(b) is included in the combination, it must not exceed 
the concentration limit specified in Sec. 346.14(b).
    (b) Any single anorectal ingredient identified in Sec. 346.10, 
346.12, 346.16, 346.18, or 346.20 may be combined with up to four 
protectants in accordance with paragraph (a) of this section.
    (c) Any single local anesthetic identified in Sec. 346.10 may be 
combined with any single vasoconstrictor identified in Sec. 346.12.
    (d) Any single local anesthetic identified in Sec. 346.10 may be 
combined with any single astringent identified in Sec. 346.18.
    (e) Any single local anesthetic identified in Sec. 346.10 may be 
combined with any single keratolytic identified in Sec. 346.20.
    (f) Any single vasoconstrictor identified in Sec. 346.12 may be 
combined with any single astringent identified in Sec. 346.18.
    (g) Any single analgesic, anesthetic, and antipruritic identified in 
Sec. 346.16 may be combined with any single astringent identified in 
Sec. 346.18.
    (h) Any single analgesic, anesthetic, and antipruritic identified in 
Sec. 346.16 may be combined with any single keratolytic identified in 
Sec. 346.20.
    (i) Any single astringent identified in Sec. 346.18 may be combined 
with any single keratolytic identified in Sec. 346.20.
    (j) Any single local anesthetic identified in Sec. 346.10 may be 
combined with any single vasoconstrictor identified in Sec. 346.12 and 
with any single astringent identified in Sec. 346.18.
    (k) Any single local anesthetic identified in Sec. 346.10 may be 
combined with any single astringent identified in Sec. 346.18 and with 
any single keratolytic identified in Sec. 346.20.
    (l) Any single vasoconstrictor identified in Sec. 346.12 may be 
combined with any single analgesic, anesthetic, and antipruritic 
identified in Sec. 346.16 and with any single astringent identified in 
Sec. 346.18.
    (m) Any single analgesic, anesthetic, and antipruritic identified in 
Sec. 346.16 may be combined with any single astringent identified in 
Sec. 346.18 and with any single keratolytic identified in Sec. 346.20.
    (n) Any combination of ingredients listed in paragraphs (c) through 
(m) of this section may be combined with up to four protectants in 
accordance with paragraph (a) of this section.
    (o) Any product containing calamine for use as a protectant and/or 
as an astringent and/or containing zinc oxide for use as a protectant 
and/or as an astringent may not have a total weight of zinc oxide 
exceeding 25 percent by weight per dosage unit.