Affinia Antiperspirant Deodorant Sweet Cream & Willow

AFFINIA ANTIPERSPIRANT DEODORANT SWEET CREAM AND WILLOW- aluminum zirconium tetrachlorohydrex 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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AFFINIA ANTIPERSPIRANT DEODORANT SWEET CREAM AND WILLOW
aluminum zirconium tetrachlorohydrex gly stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54473-307
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	16 g in 57 g

Ingredient Name	Strength
Inactive Ingredients
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE 100 (UNII: RO266O364U)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
GOSSYPIUM HERBACEUM SEED RESIN (UNII: X408487D9E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
C15-19 ALKANE (UNII: CI87N1IM01)
CETYL ALCOHOL (UNII: 936JST6JCN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54473-307-02	57 g in 1 APPLICATOR; Type 0: Not a Combination Product	04/12/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	04/12/2022

Labeler - Melaleuca Inc. (139760102)

Registrant - Melaleuca Inc. (139760102)

Name	Address	ID/FEI	Business Operations
Establishment
KDC/ONE Development Corporation, Inc		204006464	manufacture(54473-307)