Label: AUSTRALIAN GOLD METRO 365 MEDICATED LEAVE-IN TREATMENT STEP 3- pyrithione zinc 0.22% 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 January 17, 2020

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  • Active Ingredients

    Pyrithione Zinc 0.22%

  • Purpose

    Antidandruff

  • Indications

    • Controls the symptoms of dandruff.
    • Helps prevent 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 thouroughly 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 INGREDIENT

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

  • Other Information

    • Protect from heat.
  • Questions or Comments?

    Call toll free 1-855-548-4653

  • Australian Gold Metro 365 Medicated Leave-In Treatment Step 3

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  METRO 365 MEDICATED LEAVE-IN TREATMENT STEP 3
    pyrithione zinc 0.22% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0243
    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
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)  
    PALM OIL (UNII: 5QUO05548Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0243-3118 mL in 1 TUBE; Type 0: Not a Combination Product10/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/12/2016
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028label(58443-0243) , manufacture(58443-0243) , analysis(58443-0243) , pack(58443-0243)
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