Label: DUKE COOLING ANTIPERSPIRANT- 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 September 20, 2021

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  • ACTIVE INGREDIENT

    active ingredients

  • DOSAGE & ADMINISTRATION

    dosage & administration

  • WARNINGS

    warnings

  • INACTIVE INGREDIENT

    inactive ingredients

  • INDICATIONS & USAGE

    indications & usage

  • PURPOSE

    purpose

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PRINCIPAL DISPLAY PANEL

    package label principal

  • INGREDIENTS AND APPEARANCE
    DUKE COOLING ANTIPERSPIRANT 
    aluminum zirconium tetrachlorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60717-904
    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 GLY0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-8 DILAURATE (UNII: FC11NGP7E6)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    MENTHOL (UNII: L7T10EIP3A)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorgrayScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60717-904-7575 g in 1 CANISTER; Type 0: Not a Combination Product09/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35009/20/2021
    Labeler - RNA PHARMA, LLC (079103999)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNA PHARMA, LLC079103999manufacture(60717-904)
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