[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: 21CFR350.10]

[Page 288-289]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 350_ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                      Subpart B_Active Ingredients
 
Sec.  350.10  Antiperspirant active ingredients.


    The active ingredient of the product consists of any of the 
following within the established concentration and dosage formulation. 
Where applicable, the ingredient must meet the aluminum to chloride, 
aluminum to zirconium, and aluminum plus zirconium to chloride atomic 
ratios described in the U.S. Pharmacopeia-National Formulary. The 
concentration of ingredients in paragraphs (b) through (j) of this 
section is calculated on an anhydrous basis, omitting from the 
calculation any buffer component present in the compound, in an aerosol 
or nonaerosol dosage form. The concentration of ingredients in 
paragraphs (k) through (r) of this section is calculated on an anhydrous 
basis, omitting from the calculation any buffer component present in the 
compound, in a nonaerosol dosage form. The labeled declaration of

[[Page 289]]

the percentage of the active ingredient should exclude any water, buffer 
components, or propellant.
    (a) Aluminum chloride up to 15 percent, calculated on the 
hexahydrate form, in an aqueous solution nonaerosol dosage form.
    (b) Aluminum chlorohydrate up to 25 percent.
    (c) Aluminum chlorohydrex polyethylene glycol up to 25 percent.
    (d) Aluminum chlorohydrex propylene glycol up to 25 percent.
    (e) Aluminum dichlorohydrate up to 25 percent.
    (f) Aluminum dichlorohydrex polyethylene glycol up to 25 percent.
    (g) Aluminum dichlorohydrex propylene glycol up to 25 percent.
    (h) Aluminum sesquichlorohydrate up to 25 percent.
    (i) Aluminum sesquichlorohydrex polyethylene glycol up to 25 
percent.
    (j) Aluminum sesquichlorohydrex propylene glycol up to 25 percent.
    (k) Aluminum zirconium octachlorohydrate up to 20 percent.
    (l) Aluminum zirconium octachlorohydrex gly up to 20 percent.
    (m) Aluminum zirconium pentachlorohydrate up to 20 percent.
    (n) Aluminum zirconium pentachlorohydrex gly up to 20 percent.
    (o) Aluminum zirconium tetrachlorohydrate up to 20 percent.
    (p) Aluminum zirconium tetrachlorohydrex gly up to 20 percent.
    (q) Aluminum zirconium trichlorohydrate up to 20 percent.
    (r) Aluminum zirconium trichlorohydrex gly up to 20 percent.