1/17/2024 0 Comments Hemorrhoid cream applicator![]() ![]() (ii) For products containing epinephrine or epinephrine hydrochloride identified in § 346.12 (b) and (c) for external use only, and for products containing ephedrine sulfate or phenylephrine hydrochloride identified in § 346.12 (a) and (d). "For the temporary relief of" (select one or more of the following: "pain," "soreness," or "burning"). (i) For products for external use only containing any ingredient identified in § 346.10. In addition to the indication identified in paragraph (b)(1) of this section, the labeling of the product intended for external or intrarectal use may also contain the following indications, as appropriate. Indications applicable to each active ingredient of the product may be combined to eliminate duplicative words or phrases so that the resulting indication is clear and understandable. ![]() (1) ("For the temporary relief of," "Gives temporary relief of," or "Helps relieve the") (As an option, select one or both of the following: "local" or "anorectal") 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 delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. The labeling of the product states, under the heading "Indications," any of the phrases listed in paragraph (b) of this section, as appropriate. 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)." Unless otherwise specified, the labeling in this subpart is applicable to anorectal drug products for both external and intrarectal use. 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. 346.50 Labeling of anorectal drug products. PART 346 - ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE The information on this page is current as of Jun 07, 2023.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). ![]()
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