---
kind: "section"
citation: "21 C.F.R. § 346.22"
title: "21"
number: "346.22"
heading: "Permitted combinations of anorectal active ingredients."
url: "https://uscodex.org/cfr/21/346.22"
---

# §346.22. Permitted combinations of anorectal active ingredients.

- (a) Any two, three, or four protectants identified in [§ 346.14(a)](/cfr/21/346.14.md?p=a) may be combined, except aluminum hydroxide gel in [§ 346.14(a)(1)](/cfr/21/346.14.md?p=a-1) and kaolin in [§ 346.14(a)(5)](/cfr/21/346.14.md?p=a-5) may not be combined with any ingredient in [§ 346.14(a)](/cfr/21/346.14.md?p=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)](/cfr/21/346.14.md?p=b) is included in the combination, it must not exceed the concentration limit specified in [§ 346.14(b)](/cfr/21/346.14.md?p=b).
- (b) Any single anorectal ingredient identified in § [346.10](/cfr/21/346.10.md), [346.12](/cfr/21/346.12.md), [346.16](/cfr/21/346.16.md), [346.18](/cfr/21/346.18.md), or [346.20](/cfr/21/346.20.md) may be combined with up to four protectants in accordance with [paragraph (a)](#a) of this section.
- (c) Any single local anesthetic identified in [§ 346.10](/cfr/21/346.10.md) may be combined with any single vasoconstrictor identified in [§ 346.12](/cfr/21/346.12.md).
- (d) Any single local anesthetic identified in [§ 346.10](/cfr/21/346.10.md) may be combined with any single astringent identified in [§ 346.18](/cfr/21/346.18.md).
- (e) Any single local anesthetic identified in [§ 346.10](/cfr/21/346.10.md) may be combined with any single keratolytic identified in [§ 346.20](/cfr/21/346.20.md).
- (f) Any single vasoconstrictor identified in [§ 346.12](/cfr/21/346.12.md) may be combined with any single astringent identified in [§ 346.18](/cfr/21/346.18.md).
- (g) Any single analgesic, anesthetic, and antipruritic identified in [§ 346.16](/cfr/21/346.16.md) may be combined with any single astringent identified in [§ 346.18](/cfr/21/346.18.md).
- (h) Any single analgesic, anesthetic, and antipruritic identified in [§ 346.16](/cfr/21/346.16.md) may be combined with any single keratolytic identified in [§ 346.20](/cfr/21/346.20.md).
- (i) Any single astringent identified in [§ 346.18](/cfr/21/346.18.md) may be combined with any single keratolytic identified in [§ 346.20](/cfr/21/346.20.md).
- (j) Any single local anesthetic identified in [§ 346.10](/cfr/21/346.10.md) may be combined with any single vasoconstrictor identified in [§ 346.12](/cfr/21/346.12.md) and with any single astringent identified in [§ 346.18](/cfr/21/346.18.md).
- (k) Any single local anesthetic identified in [§ 346.10](/cfr/21/346.10.md) may be combined with any single astringent identified in [§ 346.18](/cfr/21/346.18.md) and with any single keratolytic identified in [§ 346.20](/cfr/21/346.20.md).
- (l) Any single vasoconstrictor identified in [§ 346.12](/cfr/21/346.12.md) may be combined with any single analgesic, anesthetic, and antipruritic identified in [§ 346.16](/cfr/21/346.16.md) and with any single astringent identified in [§ 346.18](/cfr/21/346.18.md).
- (m) Any single analgesic, anesthetic, and antipruritic identified in [§ 346.16](/cfr/21/346.16.md) may be combined with any single astringent identified in [§ 346.18](/cfr/21/346.18.md) and with any single keratolytic identified in [§ 346.20](/cfr/21/346.20.md).
- (n) Any combination of ingredients listed in [paragraphs (c) through (m)](#c..m) of this section may be combined with up to four protectants in accordance with [paragraph (a)](#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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.