[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR328.10]

[Page 200]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 328_OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT 
 
                          Subpart B_Ingredients
 
Sec.  328.10  Alcohol.


    (a) Any over-the-counter (OTC) drug product intended for oral 
ingestion shall not contain alcohol as an inactive ingredient in 
concentrations that exceed those established in this part, unless a 
specific exemption, as provided in paragraph (e) or (f) of this section, 
has been approved.
    (b) For any OTC drug product intended for oral ingestion and labeled 
for use by adults and children 12 years of age and over, the amount of 
alcohol in the product shall not exceed 10 percent.
    (c) For any OTC drug product intended for oral ingestion and labeled 
for use by children 6 to under 12 years of age, the amount of alcohol in 
the product shall not exceed 5 percent.
    (d) For any OTC drug product intended for oral ingestion and labeled 
for use by children under 6 years of age, the amount of alcohol in the 
product shall not exceed 0.5 percent.
    (e) The Food and Drug Administration will grant an exemption from 
paragraphs (b), (c), and (d) of this section where appropriate, upon 
petition under the provisions of Sec.  10.30 of this chapter. 
Appropriate cause, such as a specific solubility or manufacturing 
problem, must be adequately documented in the petition. Decisions with 
respect to requests for exemption shall be maintained in a permanent 
file for public review by the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.
    (f) Ipecac syrup is exempt from the provisions of paragraph (d) of 
this section.
    (g) The following drugs are temporarily exempt from the provisions 
of paragraphs (b), (c), and (d) of this section:
    (1) Aromatic Cascara Fluidextract.
    (2) Cascara Sagrada Fluidextract.
    (3) Orally ingested homeopathic drug products.

[60 FR 13595, Mar. 13, 1995, as amended at 61 FR 58630, Nov. 18, 1996; 
68 FR 24879, May 9, 2003]