Label: AFFINIA ANTIPERSPIRANT DEODORANT VANILLA MUSK AND JASMINE- aluminum zirconium trichlorohydrex gly stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 4, 2023

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  • DOSAGE & ADMINISTRATION

    Dosage and administration section

  • INACTIVE INGREDIENT

    inactive ingredient section

  • INDICATIONS & USAGE

    indication and usage section

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach section

  • PURPOSE

    purpose section

  • WARNINGS

    Warnings Section

  • ACTIVE INGREDIENT

    Active Ingredient Section

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    AFFINIA ANTIPERSPIRANT DEODORANT  VANILLA MUSK AND JASMINE
    aluminum zirconium trichlorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-338
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY16 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GOSSYPIUM HERBACEUM SEED RESIN (UNII: X408487D9E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-338-0257 g in 1 APPLICATOR; Type 0: Not a Combination Product04/12/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35004/12/2022
    Labeler - Melaleuca, Inc. (139760102)
    Registrant - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    KDC/ONE Development Corporation, Inc204006464manufacture(54473-338)
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