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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]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
 
PART 346ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
 

Subpart B--Active Ingredients

Sec. 346.10 Local anesthetic active ingredients.

The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient:

(a) Benzocaine 5 to 20 percent.

(b) Benzyl alcohol 1 to 4 percent.

(c) Dibucaine 0.25 to 1 percent.

(d) Dibucaine hydrochloride 0.25 to 1 percent.

(e) Dyclonine hydrochloride 0.5 to 1 percent.

(f) Lidocaine 2 to 5 percent.

(g) Pramoxine hydrochloride 1 percent.

(h) Tetracaine 0.5 to 1 percent.

(i) Tetracaine hydrochloride 0.5 to 1 percent.

Sec. 346.12 Vasoconstrictor active ingredients.

The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient.

(a) Ephedrine sulfate 0.1 to 1.25 percent.

(b) Epinephrine 0.005 to 0.01 percent.

(c) Epinephrine hydrochloride 0.005 to 0.01 percent.

(d) Phenylephrine hydrochloride 0.25 percent.

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 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 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.

Sec. 346.16 Analgesic, anesthetic, and antipruritic active ingredients.

The active ingredient of the product consists of any of the following when used within the concentration range established for each ingredient:

(a) Camphor 0.1 to 3 percent.

(b) Juniper tar 1 to 5 percent.

(c) Menthol 0.1 to 1 percent.

Sec. 346.18 Astringent active ingredients.

The active ingredient of the product consists of any of the following when used within the concentration range established for each ingredient:

(a) Calamine, within a concentration range of 5 to 25 percent by weight per dosage unit (based on the zinc oxide content of calamine).

(b) Witch hazel, 10 to 50 percent.

(c) Zinc oxide, within a concentration range of 5 to 25 percent by weight per dosage unit.

[55 FR 31779, Aug. 3, 1990, as amended at 59 FR 28767, June 3, 1994]

Sec. 346.20 Keratolytic active ingredients.

The active ingredient of the product consists of any of the following when used within the concentration range established for each ingredient:

(a) Alcloxa 0.2 to 2 percent.

(b) Resorcinol 1 to 3 percent.

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.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.

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