Label: AUSTRALIAN GOLD METRO 365 MEDICATED 2 IN 1 ANTI-DANDRUFF- pyrithione zinc 1% 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

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredients

    Pyrithione Zinc 1%

  • Purpose

    Antidandruff

  • Indications

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

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

  • Other Information

    • Protect from heat.
  • Questions or Comments?

    Call toll free 1-855-548-4653

  • Australian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  METRO 365 MEDICATED 2 IN 1 ANTI-DANDRUFF
    pyrithione zinc 1% shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0242
    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
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0242-5266 mL in 1 TUBE; Type 0: Not a Combination Product10/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/07/2016
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028manufacture(58443-0242) , label(58443-0242) , analysis(58443-0242) , pack(58443-0242)
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

More Info on this Drug

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