Label: AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL

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 ingredients

    Pyrithione Zinc 1%

  • Purpose

    Antidanruff

  • Uses

    • For the relief of the symptoms of dandruff.
    • Helps Stop recurrence of scalp itching and flaking associated with dandruff.
  • Warnings

    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

    • If Condition worsens or does not improve after regular use of this product as directed

    Keep out of reach of children.

    • If product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Shake well
    • Wet hair, lather and massage into scalp, rinse hair thoroughly, repeat if desired,
    • For best results use at least twice a week or as directed by a doctor.
    • Children under 6 months of age: ask a doctor.
  • Inactive Ingrediets:

    Acrylates Copolymer, Caprylyl Glycol, Chlorphenesin, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Dimethicone, Disodium EDTA, Fragrance, Glycol Stearate, Phenoxyethanol, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Stearyl Dihydroxypropyldimonium Oligosaccharides, Water

  • Questions or Comments?

    Call toll free 1-855-548-4653

  • PRINCIPAL DISPLAY PANEL - 266 mL  Bottle Label PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label

    Defense

    Zone

    Medicated 2 in 1

    Shampoo &

    Conditioner

    Anti-Dandruff

    Step

    2

    Gradual Release

    Provides Long Lating Results

    9 FL OZ (266mL)

    PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    Defense

    Zone

    Medicated

    2 in 1

    Shampoo &

    Conditioner

    Anti-Dandruff

    Step

    2

    Gradual Release

    2 FL OZ (59mL)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL- 59 mL Bottle

    Defense

    Zone

    Medicated

     2 in 1

    Shampoo &

    Conditioner

    Anti-Dandruff

    Step

    2

    Gradual Release

    2 FL OZ (59mL)

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD DEFENSE ZONE  ANTI-DANDRUFF STEP 2
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10.32 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    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:58443-0180-5266 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2015
    2NDC:58443-0180-359 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/01/2015
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0180) , pack(58443-0180) , manufacture(58443-0180) , analysis(58443-0180)
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