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Australian Gold Defense Zone Anti-dandruff Leave-in Treatment

Medically reviewed on July 17, 2018

Dosage form: lotion
Ingredients: PYRITHIONE ZINC 2.14mg in 1mL
Labeler: Prime Enterprises, Inc.
NDC Code: 58443-0184

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.

PRINCIPAL DISPLAY PANEL - 118 mL  Bottle Label

Defense

Zone

Medicated 

LEAVE-IN

TREATMENT

Anti-Dandruff

Step

3

Relieves Dryness

Locks in Moisture

4 FL OZ (118mL)

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?

Call toll free 1-855-548-4653

AUSTRALIAN GOLD DEFENSE ZONE  ANTI-DANDRUFF LEAVE-IN TREATMENT
pyrithione zinc lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0184
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
CAPRYLYL GLYCOL 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
CETRIMONIUM BROMIDE 
CHLORPHENESIN 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
PALM OIL 
GLYCERIN 
PHENOXYETHANOL 
SODIUM HYDROXIDE 
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) 
WATER 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58443-0184-3118 mL in 1 BOTTLE
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/FEIOperations
Prime Enterprises, Inc.101946028label(58443-0184), pack(58443-0184), manufacture(58443-0184), analysis(58443-0184)

 
Prime Enterprises, Inc.

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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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