AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2- pyrithione zinc shampoo

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 ingredients

Pyrithione Zinc 1%

Purpose

Antidanruff

Uses

• For the relief of the symptoms of dandruff.
• Helps Stop 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 thorougly with water.

Stop use and ask a doctor if

• If Condition worsens or does not improve after regular use of this product as directed

Keep out of reach of children.

• If product is 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 Ingrediets:

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

Questions or Comments?

Call toll free 1-855-548-4653

PRINCIPAL DISPLAY PANEL - 266 mL  Bottle Label PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

Defense

Zone

Medicated 2 in 1

Shampoo &

Conditioner

Anti-Dandruff

Step

2

Gradual Release

Provides Long Lating Results

9 FL OZ (266mL)

Defense

Zone

Medicated

2 in 1

Shampoo &

Conditioner

Anti-Dandruff

Step

2

Gradual Release

2 FL OZ (59mL)

PRINCIPAL DISPLAY PANEL

Defense

Zone

Medicated

 2 in 1

Shampoo &

Conditioner

Anti-Dandruff

Step

2

Gradual Release

2 FL OZ (59mL)

INGREDIENTS AND APPEARANCE

AUSTRALIAN GOLD DEFENSE ZONE  ANTI-DANDRUFF STEP 2
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0180
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10.32 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCOL STEARATE (UNII: 0324G66D0E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
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: 58443-0180-5	266 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2015
2	NDC: 58443-0180-3	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/01/2015

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0180) , pack(58443-0180) , manufacture(58443-0180) , analysis(58443-0180)