Label: AXE- 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 June 1, 2011

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  • ACTIVE INGREDIENT

    Active ingredient

    Aluminum Zirconium Tetrachlorohydrex GLY(18.2%)

  • PURPOSE

    Purpose
    anti-perspirant
  • INDICATIONS & USAGE

    Uses
    · reduces underarm wetness
    · 24 hour protection
  • WARNINGS

    Warnings
    For external use only

    Do not use on broken skin

    Ask a doctor before use if you have kidney disease

    Stop use if rash or irritation occurs

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    ·     apply to underarms only
    · turn dial to raise product
    · to ensure product appears clear on skin, do not overapply
    · replace cap
  • INACTIVE INGREDIENT

    Inactive ingredients

    Cyclopentasiloxane, PPG-14 Butyl Ether, Stearyl Alcohol, Hydrogenated Castor Oil, PEG-8 Distearate, Talc, Fragrance (Parfum), BHT
  • QUESTIONS

    Questions?

    Call toll-free 1-800-450-7580

  • PRINCIPAL DISPLAY PANEL

    Sharp Focus 2.7 oz PDP
    Axe Dry Sharp Focus 2.7 PDP
  • INGREDIENTS AND APPEARANCE
    AXE   DRY SHARP FOCUS
    aluminum zirconium tetrachlorohydrex gly stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1168
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aluminum Zirconium Tetrachlorohydrex GLY (UNII: 8O386558JE) (Aluminum cation - UNII:3XHB1D032B) Aluminum Zirconium Tetrachlorohydrex GLY18.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PEG-8 DISTEARATE (UNII: 7JNC8VN07M)  
    TALC (UNII: 7SEV7J4R1U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1168-176 g in 1 CONTAINER
    2NDC:64942-1168-248 g in 1 CONTAINER
    3NDC:64942-1168-314 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35006/01/2011
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Raeford HPCNA131411576manufacture
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