Label: AFFINIA ANTIPERSPIRANT DEODORANT SWEET CREAM AND WILLOW- aluminum zirconium tetrachlorohydrex 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 April 12, 2022

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  • ACTIVE INGREDIENT

    active ingredients

  • DOSAGE & ADMINISTRATION

    Dosage and administration section

  • INACTIVE INGREDIENT

    inactive ingredients

  • INDICATIONS & USAGE

    ind

  • KEEP OUT OF REACH OF CHILDREN

    keep

  • PURPOSE

    purp

  • WARNINGS

    warning section

  • PRINCIPAL DISPLAY PANEL

    Package label. principal display panel

  • INGREDIENTS AND APPEARANCE
    AFFINIA ANTIPERSPIRANT DEODORANT  SWEET CREAM AND WILLOW
    aluminum zirconium tetrachlorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-307
    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
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-307-0257 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(54473-307)
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