Label: AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT- pyrithione zinc lotion

  • 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 January 17, 2020

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  • Active ingredient:

    Pyrithione Zinc 0.22%

  • Purpose

    Antidanruff

  • Indications:

    • Controls the symptoms of dandruff.
    • Helps prevent recurrence of scalp itching and flaking associated with dandruff.
  • Warning:

    For external use only.

    When using this product

    • Avoid contact with the eyes. If contact occurs, rinse eyes thorougly 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
  • Directions:

    • Shake well.
    • Use after shampooing and towel drying hair. Part hair section by section. Apply directly onto the scalp and spread using fingertips. Gently massage into scalp. Leave in.
    • Apply to affected areas one to four times daily or as directed by a doctor
    • Children under 6 months of age: ask a doctor.
  • Inactive Ingrediets:

    Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetrimonium Bromide, Cetyl Alcohol, Chlorphenesin, Citric Acid, Disodium EDTA, Elaeis Guineensis (Palm) Oil, Fragrance, Glycerin, Phenoxyethanol, Sodium Hydroxide, Stearyl Dihydroxypropyldisodium Oligosaccharides, Water

  • Questions or Comments?

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  • PRINCIPAL DISPLAY PANEL - 59 mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    Defense

    Zone

    Medicated 

    LEAVE-IN

    TREATMENT

    Anti-Dandruff

    Step

    3

    Relieves Dryness

    2 FL OZ (59mL)

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD DEFENSE ZONE  ANTI-DANDRUFF LEAVE-IN TREATMENT
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0186
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.14 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PALM OIL (UNII: 5QUO05548Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0186-359 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/01/2015
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0186) , pack(58443-0186) , manufacture(58443-0186) , analysis(58443-0186)
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