AUSTRALIAN GOLD METRO 365 MEDICATED 2 IN 1 ANTI-DANDRUFF- pyrithione zinc 1% shampoo
Prime Enterprises Inc.

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.

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Australian Gold Metro 365 Medicated 2 in 1 Anti - Dandruff

Active Ingredients

Pyrithione Zinc 1%

Purpose

Antidandruff

Indications

Controls the symptoms of dandruff.
Helps prevent recurrence of scalp itching and flaking associated with antidandruff.

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
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.

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

Other Information

Protect from heat.

Questions or Comments?

Call toll free 1-855-548-4653

Australian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff

Principal Display Image

AUSTRALIAN GOLD METRO 365 MEDICATED 2 IN 1 ANTI-DANDRUFF
pyrithione zinc 1% shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0242
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CHLORPHENESIN (UNII: I670DAL4SZ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCOL STEARATE (UNII: 0324G66D0E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
COCO MONOETHANOLAMIDE (UNII: C80684146D)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0242-5	266 mL in 1 TUBE; Type 0: Not a Combination Product	10/07/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	10/07/2016

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc.		101946028	manufacture(58443-0242) , label(58443-0242) , analysis(58443-0242) , pack(58443-0242)