Label: AXE ANTIDANDRUFF STYLING- pyrithione zinc cream

  • 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 February 20, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione Zinc (0.2%)

  • PURPOSE

    Purpose

    Anti-dandruff

  • INDICATIONS & USAGE

    Use

    Helps prevent and control recurrence of itching and flaking associated with dandruff.

  • WARNINGS

    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 this and all drugs out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply to affected areas one to four times daily or as directed by a doctor.

    • Massage product into scalp to relieve dryness and itch.

    • Style hair as usual.​

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water (Aqua), Cetearyl Alcohol, Steareth-20, Propylene Glycol, PPG-5-Ceteth-20, Isopropyl Palmitate, VP/VA Copolymer, Polyquaternium-68, Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer, Fragrance (Parfum), Steareth-2, Glycerin, DMDM Hydantoin, PEG-100 Stearate, Sodium Polyacrylate, Hydrogenated Polydecene, Butylene Glycol, Trideceth-6, Iodopropynyl Butylcarbamate, Blue 1 (CI 42090)

  • QUESTIONS

    Questions, Comments?

    Call 1-800-372-6389

  • PDP

    Axe Antidandruff Styling Cream

  • INGREDIENTS AND APPEARANCE
    AXE  ANTIDANDRUFF STYLING
    pyrithione zinc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1289
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    STEARETH-2 (UNII: V56DFE46J5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1289-190 g in 1 TUBE
    2NDC:64942-1289-218 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/19/2013
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thibiant International, Inc.083913913manufacture(64942-1289)
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