Label: AXE FREEZE ANTIDANDRUFF- 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 April 24, 2014

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient
    Pyrithione Zinc (1.0%)

  • PURPOSE

    Purpose

    Anti-dandruff

  • INDICATIONS & USAGE

    Use helps control scalp itching and flaking associated with dandruff.

  • WARNINGS

    Warnings
    For external use only

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center Right Away.

    Avoid contact with eyes.  Product contains menthol.  If you experience discomfort, please stop use.

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

  • DOSAGE & ADMINISTRATION

    Direction

    ·  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, Menthol, DMDM Hydantoin, Citric Acid, Guar Hydroxypropyltrimonium Chloride, TEA-Dodecylbenzenesulfonate, Butylene Glycol, Iodopropynyl Butylcarbamate, Propylene Glycol, PPG-9, Methylisothiazolinone, Methylchloroisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

  • QUESTIONS

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

  • 12 FL OZ PDP

    AxeFreezeADPDP

  • 12 FL OZ back

    AxeFreezeADPDPback

  • INGREDIENTS AND APPEARANCE
    AXE  FREEZE ANTIDANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1357
    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 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MENTHOL (UNII: L7T10EIP3A)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PPG-9 (UNII: I29VQH0G0B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1357-1355 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/02/2009
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Supply Chain Co. d/b/a Unilever043510056manufacture(64942-1357)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!