FORMULATION

Approved Active Ingredients

The final OTC antiperspirant monograph itemized the 18 active ingredients that are approved for use in antiperspirant products in the U. S. Table 2 shows each of the approved

Table 2 Antiperspirant Active Ingredients

Active ingredient

Concentration

Dosage form

Aluminum chloride

Up to 15% (calculated on hexahydrate form)

Only aqueous solution (must be nonaerosol)

Aluminum chlorohydrate

Up to 25%

Aerosol or nonaerosol

Aluminum chlorohydrex polyethylene glycol

Up to 25%

Aerosol or nonaerosol

Aluminum chlorohydrex propylene glycol

Up to 25%

Aerosol or nonaerosol

Aluminum dichlorohydrate

Up to 25%

Aerosol or nonaerosol

Aluminum dichlorohydrex polyethylene glycol

Up to 25%

Aerosol or nonaerosol

Aluminum dichlorohydrex propylene glycol

Up to 25%

Aerosol or nonaerosol

Aluminum sesquichlorohydrate

Up to 25%

Aerosol or nonaerosol

Aluminum sesquichlorohydrex polyethylene glycol

Up to 25%

Aerosol or nonaerosol

Aluminum sesquichlorohydrex propylene glycol

Up to 25%

Aerosol or nonaerosol

Aluminum zirconium octachlorohydrate

Up to 20%

Nonaerosol

Aluminum zirconium octachlorohydrex gly

Up to 20%

Nonaerosol

Aluminum zirconium pentachlorohydrate

Up to 20%

Nonaerosol

Aluminum zirconium pentachlorohydrex gly

Up to 20%

Nonaerosol

Aluminum zirconium tetrachlorohydrate

Up to 20%

Nonaerosol

Aluminum zirconium tetrachlorohydrex gly

Up to 20%

Nonaerosol

Aluminum zirconium trichlorohydrate

Up to 20%

Nonaerosol

Aluminum zirconium trichlorohydrex gly

Up to 20%

Nonaerosol

ingredients, concentration limits, and dosage forms/types in which the approved active can be formulated.

There are no specific active ingredient lists specified by the EU or Japan.

Updated: June 23, 2015 — 12:02 am