Label: AXE SIGNATURE DAILY DANDRUFF DEFENSE ANTI-DANDRUFF- pyrithione zinc shampoo

  • 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 December 7, 2022

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  • Drug Facts

  • Active ingredient

    With Pyrithione Zinc (1.0% WW)

  • Purpose

    anti-dandruff

  • Uses

    • helps control scalp itching and flaking associated with dandruff.
  • Warnings

    For External Use Only

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Squeeze. Lather for several minutes. Rinse.
    • Use at least twice a week or as directed by a doctor.
  • Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Fragrance (Parfum), Carbomer, Dimethiconol, DMDM Hydantoin, Citric Acid, PPG-9, Guar Hydroxypropyltrimonium Chloride, TEA-Dodecylbenzenesulfonate, Butylene Glycol, Iodopropynyl Butylcarbamate, Methylchloroisothiazolinone, Methylisothiazolinone

  • Questions?

    1-800-450-7580

  • SPL UNCLASSIFIED SECTION

    Consult a doctor prior to use in children under 2 years of age.

  • Packaging

    AXE

  • INGREDIENTS AND APPEARANCE
    AXE   SIGNATURE DAILY DANDRUFF DEFENSE ANTI-DANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1483
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PPG-9 (UNII: I29VQH0G0B)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1483-1355 mL in 1 CONTAINER; Type 0: Not a Combination Product11/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H11/10/2016
    Labeler - Conopco, Inc. d/b/a Unilever (001375088)
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