[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR328.50]

[Page 201]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 328_OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION
THAT CONTAIN ALCOHOL--Table of Contents
 
                           Subpart C_Labeling
 
Sec. 328.50  Principal display panel of all OTC drug products 
intended for oral ingestion that contain alcohol.


    (a) The amount (percentage) of alcohol present in a product shall be 
stated in terms of percent volume of absolute alcohol at 60 [deg]F 
(15.56 [deg]C) in accordance with Sec. 201.10(d)(2) of this chapter.
    (b) A statement expressing the amount (percentage) of alcohol 
present in a product shall appear prominently and conspicuously on the 
``principal display panel,'' as defined in Sec. 201.60 of this chapter. 
For products whose principal display panel is on the immediate container 
label and that are not marketed in another retail package (e.g., an 
outer box), the statement of the percentage of alcohol present in the 
product shall appear prominently and conspicuously on the ``principal 
display panel'' of the immediate container label.
    (c) For products whose principal display panel is on the retail 
package and the retail package is not the immediate container, the 
statement of the percentage of alcohol present in the product shall also 
appear on the immediate container label; it may appear anywhere on that 
label in accord with section 502(e) of the Federal Food, Drug, and 
Cosmetic Act.
    (d) The statement expressing the amount (percentage) of alcohol 
present in the product shall be in a size reasonably related to the most 
prominent printed matter on the panel or label on which it appears, and 
shall be in lines generally parallel to the base on which the package 
rests as it is designed to be displayed.
    (e) For a product to state in its labeling that it is ``alcohol 
free,'' it must contain no alcohol (0 percent).
    (f) For any OTC drug product intended for oral ingestion containing 
over 5 percent alcohol and labeled for use by adults and children 12 
years of age and over, the labeling shall contain the following 
statement in the directions section: ``Consult a physician for use in 
children under 12 years of age.''
    (g) For any OTC drug product intended for oral ingestion containing 
over 0.5 percent alcohol and labeled for use by children ages 6 to under 
12 years of age, the labeling shall contain the following statement in 
the directions section: ``Consult a physician for use in children under 
6 years of age.''
    (h) When the direction regarding age in paragraph (e) or (f) of this 
section differs from an age-limiting direction contained in any OTC drug 
monograph in this chapter, the direction containing the more stringent 
age limitation shall be used.