Label: AXE ARMOR ANTIDANDRUFF 2 IN 1- 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 June 7, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient
    Pyrithione Zinc (1.0%)

  • PURPOSE

    Purpose
    Anti-dandruff
  • INDICATIONS & USAGE

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

    Directions
    ·  Squeeze. Lather. Rinse
    ·  For best results, use at least twice a week or as directed by a doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients
    Water (Aqua),  Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Fragrance (Parfum), Carbomer,  Dimethiconol, Glycol Distearate, DMDM Hydantoin,  Guar Hydroxypropyltrimonium Chloride, TEA-Dodecylbenzenesulfonate,  Citric Acid, Iodopropynyl Butylcarbamate, Methylchloroisothiazolinone, Methylisothiazolinone,  PPG-9, Mica (CI 77019), Titanium Dioxide (CI 77891),  Blue 1 (CI 42090), Red 33 (CI 17200)
  • QUESTIONS

    theaxeeffect.com
    QUESTIONS/COMMENTS?
    1-800-450-7580

  • PRINCIPAL DISPLAY PANEL

    PDP 12 oz front
    Axe Armor AntiDandruff Shampoo 12oz front PDP
  • PRINCIPAL DISPLAY PANEL

    PDP 12 oz back
    Axe Armor AntiDandruff Shampoo 12oz back PDP
  • INGREDIENTS AND APPEARANCE
    AXE  ARMOR ANTIDANDRUFF 2 IN 1
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1186
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione - UNII:6GK82EC25D) Pyrithione Zinc1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PPG-9 (UNII: I29VQH0G0B)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1186-1650 mL in 1 CONTAINER
    2NDC:64942-1186-2355 mL in 1 CONTAINER
    3NDC:64942-1186-3443 mL in 1 CONTAINER
    4NDC:64942-1186-450 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/23/2008
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Supply Chain Co. d/b/a Unilever043510056manufacture
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