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Australian Gold Metro 365 Medicated Leave-In Treatment Step 3

Medically reviewed on October 12, 2016.

Dosage form: cream
Ingredients: PYRITHIONE ZINC 2.14mg in 1mL
Labeler: Prime Enterprises Inc.
NDC Code: 58443-0243

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.

Australian Gold Metro 365 Medicated Leave In Treatment Step 3

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.

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

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC2.14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN 
CETRIMONIUM BROMIDE 
PALM OIL 
EDETATE DISODIUM 
GLYCERIN 
PHENOXYETHANOL 
SODIUM HYDROXIDE 
CETYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
CAPRYLYL GLYCOL 
WATER 
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) 
CITRIC ACID MONOHYDRATE 
CETOSTEARYL ALCOHOL 
PROPYLENE GLYCOL 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58443-0243-3118 mL in 1 TUBE
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/FEIOperations
Prime Enterprises Inc.101946028label(58443-0243), manufacture(58443-0243), analysis(58443-0243), pack(58443-0243)

 
Prime Enterprises Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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