Alloy Antiperspirant & Deodorant

ALLOY ANTIPERSPIRANT AND DEODORANT- aluminum zirconium trichlorohydrex gly stick
Melaleuca, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ALLOY ANTIPERSPIRANT AND DEODORANT
aluminum zirconium trichlorohydrex gly stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54473-339
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY (UNII: T27D6T99LH) (ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY - UNII:T27D6T99LH)	ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY	10.24 g in 64 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
C15-19 ALKANE (UNII: CI87N1IM01)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
BALANITES AEGYPTIACA SEED OIL (UNII: 75T177G59E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54473-339-02	64 g in 1 APPLICATOR; Type 0: Not a Combination Product	04/20/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	04/20/2022

Labeler - Melaleuca, Inc (139760102)

Registrant - Melaleuca, Inc (139760102)

Name	Address	ID/FEI	Business Operations
Establishment
KDC/ONE Development Corporation, Inc		204006464	manufacture(54473-339)