(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.