Title 21 CFR reference

(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 212 unless otherwise noted.

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.

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.

(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…

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.

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]

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.

(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…

As used in this part: Analgesic, anesthetic drug.(a) A topically (externally) applied drug that relieves pain by depressing cutaneous sensory receptors. Anorectal drug.(b) A drug that is used to relieve symptoms caused by anorectal disorders in the anal canal, perianal area, and/or the lower rectal areas. Antipruritic drug.(c) A topically (externally) applied drug that relieves itching by depressing cutaneous sensory receptors. Astringent drug.(d) A drug that is applied topically (externally) to the skin or mucous membranes for a local and limited protein coagulant effect. External use.(e) Topical application of an anorectal drug product to the skin of the perianal area and/or the skin of the anal canal. Intrarectal use.(f) Topical application of an anorectal drug product to the mucous membrane of the rectum. Keratolytic drug.(g) A drug that causes desquamation (loosening) and debridement or sloughing of the surface cells of the epidermis. Local anesthetic drug.(h) A drug that produces local disappearance of pain, burning, itching, irritation, and/or discomfort by reversibly blocking nerve conduction when applied to nerve tissue in appropriate concentrations. Protectant…

The labeling of the product contains the following information for anorectal ingredients identified in §§ 346.10, 346.12, 346.14, 346.16, 346.18, and 346.20, and for combinations of anorectal ingredients identified in § 346.22. Unless otherwise specified, the labeling in this subpart is applicable to anorectal drug products for both external and intrarectal use. Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as “anorectal (hemorrhoidal),” “hemorrhoidal,” “hemorrhoidal (anorectal) (insert dosage form, e.g., cream, lotion, or ointment).” Indications.(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or…

Indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. Statement of identity.(a) For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity established in § 346.50(a). For a combination drug product that does not have an established name, the labeling of the product states the statement of identity established in § 346.50(a). Indications.(b) The labeling of the product states, under the heading “Indications,” the indication(s) for each ingredient in the combination, as established in the indications sections of this subpart. Warnings.(c) The labeling of the product states, under the heading “Warnings,” the warning(s) for each ingredient in the combination, as established in the warnings sections of this subpart. Directions.(d) The labeling of the product states, under the heading “Directions,” directions that conform to the directions established for each ingredient in the…