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

Australian Gold Defense Zone by

Drug Labeling and Warnings

Australian Gold Defense Zone by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL - 59 mL  Bottle Label

Defense

Zone

Medicated 

LEAVE-IN

TREATMENT

Anti-Dandruff

Step

3

Relieves Dryness

2 FL OZ (59mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0186
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0186-3	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2015

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

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0186) , pack(58443-0186) , manufacture(58443-0186) , analysis(58443-0186)