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?

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PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Defense

Zone

Medicated

LEAVE-IN

TREATMENT

Anti-Dandruff

Step

Relieves Dryness

Locks in Moisture

4 FL OZ (118mL)

AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF LEAVE-IN TREATMENT
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0184
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2.14 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)
CHLORPHENESIN (UNII: I670DAL4SZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PALM OIL (UNII: 5QUO05548Z)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0184-3	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	08/01/2015

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0184) , pack(58443-0184) , manufacture(58443-0184) , analysis(58443-0184)