---
kind: "section"
citation: "21 C.F.R. § 348.50"
title: "21"
number: "348.50"
heading: "Labeling of external analgesic drug products."
url: "https://uscodex.org/cfr/21/348.50"
---

# §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)](#b) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in [paragraph (b)](#b) of this section, may also be used, as provided in [§ 330.1(c)(2)](/cfr/21/330.1.md?p=c-2) of this chapter, subject to the provisions of [section 502](/cfr/21/502.md) of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in [section 301(d)](/cfr/21/301.md?p=d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of [section 505(a)](/cfr/21/505.md?p=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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 57 FR 27656, June 19, 1992, unless otherwise noted.