[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR348.50]

[Page 269-270]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 348--EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                           Subpart C--Labeling
 
Sec. 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 
Sec. 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 
Sec. 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 
Sec. 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 
Sec. 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.''

[[Page 270]]

    (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 
Sec. 348.10(a)--(i) For products containing benzocaine identified in 
Sec. 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 
Sec. 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.