Label: TOMMY GIRL ANTIPERSPIRANT- aluminum zirconium tetrachlorhydrex 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 August 19, 2011

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ALUMINUM ZIRCONIUM TETRACHLOROHYDREX-GLY 18.4%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: CYCLOPENTASILOXANE [] STEARYL ALCOHOL [] TALC [] PPG-14 BUTYL ETHER [] HYDROGENATED CASTOR OIL [] ARACHIDYL ALCOHOL [] FRAGRANCE (PARFUM) [] LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER

  • PURPOSE


    PURPOSE: ANTIPERSPIRANT
  • INDICATIONS & USAGE

    USE: REDUCES UNDERARM WETNESS

  • WARNINGS

    WARNINGS:

    • FOR EXTERNAL USE ONLY
    • DO NOT USE ON BROKEN SKIN
    • STOP USE IF IRRITATION OCCURS
  • ASK DOCTOR/PHARMACIST

    ASK A DOCTOR BEFORE USE IF YOU HAVE KIDNEY DISEASE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY TO UNDERARMS ONLY

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:

    TOMMY HILFIGER

       TOMMY

        GIRL

    ANTIPERSPIRANT

    DEODORANT

    STICK

    NT WT. 2.6 OZ./75 g



    TOMMY HILFIGER TOILETRIES, DISTR

    NY, NY 10022

    LABEL

     


  • INGREDIENTS AND APPEARANCE
    TOMMY GIRL ANTIPERSPIRANT   DEODORANT
    aluminum zirconium tetrachlorhydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64268-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    TALC (UNII: 7SEV7J4R1U)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64268-001-0175 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35007/01/2001
    Labeler - TOMMY HILFIGER TOILETRIES (046185765)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramis Inc.042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone618107429manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.255175580manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Center208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    STANDARD SOAP490709094manufacture