Title 21

SECTION 348.50

348.50 Labeling of external analgesic drug products.

§ 348.50 Labeling of external analgesic drug products.

(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as follows:

(1) For products containing any ingredient identified in § 348.10(a). “Male genital desensitizer.”

(2) [Reserved]

(b) Indications. 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.

(1) For products containing any ingredient identified in § 348.10(a). (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 one of the following: “retarding the onset of,” “slowing the onset of,” or “prolonging the time until”) followed by “ejaculation.”

(iv) “For reducing oversensitivity in the male in advance of intercourse.”

(2) [Reserved]

(c) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”:

(1) For products containing any ingredient identified in § 348.10(a). (i) “Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor.”

(ii) “Avoid contact with the eyes.”

(iii) “If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.”

(2) [Reserved]

(d) Directions. The labeling of the product contains the following information under the heading “Directions”:

(1) For products containing any ingredient identified in § 348.10(a) - (i) For products containing benzocaine identified in § 348.10(a)(1). “Apply a small amount to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.”

(ii) For products containing lidocaine identified in § 348.10(a)(2). “Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse.”

(2) [Reserved]

(e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.

---