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United States • Title 21 CFR • Part 348
This part of the CFR outlines the requirements for over-the-counter (OTC) external analgesic drug products for human use. It specifies conditions for general recognition as safe and effective, including scope, definitions, active ingredients, and labeling requirements.
(a) An over-the-counter external analgesic drug product in a form suitable for topical 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 21 unless otherwise noted.
The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient: Male genital desensitizers.(a) (1) Benzocaine, 3 to 7.5 percent in a water-soluble base. (2) Lidocaine in a metered spray with approximately 10 milligrams per spray. (b) [Reserved]
As used in this part: Male genital desensitizing drug product.(a) A drug product applied to the penis to help in temporarily slowing the onset of ejaculation. (b) [Reserved]
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as follows: For products containing any ingredient identified in § 348.10(a).(1) “Male genital desensitizer.” (2) [Reserved] Indications.(b) The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, 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. For products containing any ingredient identified in § 348.10(a).(1) (i) “Helps in the prevention of premature ejaculation.” (ii) “For temporary male genital desensitization, helping to slow the onset of ejaculation.” (iii) “Helps in temporarily” (select…
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