[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: 21CFR357.850]

[Page 309]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 357_MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--
 
           Subpart I_Deodorant Drug Products for Internal Use
 
Sec.  357.850  Labeling of deodorant drug products for internal use.

    (a) Statement of identity. The labeling of the product contains the 
established name of the drug, if any, and identifies the product as a 
``deodorant for internal use'' or as a ``colostomy or ileostomy 
deodorant.''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' any of the phrases listed in paragraph (b) of 
this section as appropriate. 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 bismuth subgallate identified in Sec.  
357.810(a). ``An aid to reduce odor from a colostomy or ileostomy.''
    (2) For products containing chlorophyllin copper complex identified 
in Sec.  357.810(b). (i) ``An aid to reduce odor from a colostomy or 
ileostomy.''
    (ii) ``An aid to reduce fecal odor due to incontinence.''
    (c) Warnings. The labeling of the product contains the following 
warnings under the heading ``Warnings'': (1) For products containing 
chlorophyllin copper complex identified in Sec.  357.810(b). (i) ``If 
cramps or diarrhea occurs, reduce the dosage. If symptoms persist, 
consult your doctor.''
    (ii) The warning required by Sec.  330.1(g) of this chapter 
concerning overdose is not required on products containing chlorophyllin 
copper complex identified in Sec.  357.810(b).
    (2) [Reserved]
    (d) Directions. The labeling of the product contains the following 
information under the heading ``Directions.''
    (1) For products containing bismuth subgallate identified in Sec.  
357.810(a). Adults and children 12 years of age and over: Oral dosage is 
200 to 400 milligrams up to 4 times daily. Children under 12 years of 
age: consult a doctor.
    (2) For products containing chlorophyllin copper complex identified 
in Sec.  357.810(b). Adults and children 12 years of age and over: Oral 
dosage is 100 to 200 milligrams daily in divided doses as required. If 
odor is not controlled, take up to an additional 100 milligrams daily in 
divided doses as required. The smallest effective dose should be used. 
Do not exceed 300 milligrams daily. Children under 12 years of age: 
consult a doctor.