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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2019]
[CITE: 21CFR346.22]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 346 -- ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart B--Active Ingredients

Sec. 346.22 Permitted combinations of anorectal active ingredients.

(a) Any two, three, or four protectants identified in 346.14(a) may be combined, except aluminum hydroxide gel in 346.14(a)(1) and kaolin in 346.14(a)(5) may not be combined with any ingredient in 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 346.14(b) is included in the combination, it must not exceed the concentration limit specified in 346.14(b).

(b) Any single anorectal ingredient identified in 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 346.10 may be combined with any single vasoconstrictor identified in 346.12.

(d) Any single local anesthetic identified in 346.10 may be combined with any single astringent identified in 346.18.

(e) Any single local anesthetic identified in 346.10 may be combined with any single keratolytic identified in 346.20.

(f) Any single vasoconstrictor identified in 346.12 may be combined with any single astringent identified in 346.18.

(g) Any single analgesic, anesthetic, and antipruritic identified in 346.16 may be combined with any single astringent identified in 346.18.

(h) Any single analgesic, anesthetic, and antipruritic identified in 346.16 may be combined with any single keratolytic identified in 346.20.

(i) Any single astringent identified in 346.18 may be combined with any single keratolytic identified in 346.20.

(j) Any single local anesthetic identified in 346.10 may be combined with any single vasoconstrictor identified in 346.12 and with any single astringent identified in 346.18.

(k) Any single local anesthetic identified in 346.10 may be combined with any single astringent identified in 346.18 and with any single keratolytic identified in 346.20.

(l) Any single vasoconstrictor identified in 346.12 may be combined with any single analgesic, anesthetic, and antipruritic identified in 346.16 and with any single astringent identified in 346.18.

(m) Any single analgesic, anesthetic, and antipruritic identified in 346.16 may be combined with any single astringent identified in 346.18 and with any single keratolytic identified in 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.

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