FDA.reportPublic FDA data

Australian Gold

Manufacturer
Prime Enterprises Inc.
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:04

Label at a glance#

ProductAustralian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1%

Purpose

OTC - PURPOSE SECTION

Antidandruff

Indications

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes. If contact occurs, rinse eyes thouroughly with water.

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

  • Protect from heat.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-855-548-4653

Australian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0242-52024-01-30C16284748780-11030e365-4ca2-111a-e063-dadaa90a10e2Australian Gold Metro 365 Medicated 2 in 1 Anti - Dandruff

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0242-5Australian GoldMetro 365 Medicated 2 in 1 Anti-Dandruff266 mL in 1 TUBESHAMPOO2662

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0242AUSTRALIAN GOLD METRO 365 MEDICATED 2 IN 1 ANTI-DANDRUFF (PYRITHIONE ZINC 1%) SHAMPOO [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200118_3f235977-62cd-08f5-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-024258443-0242-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENESINI670DAL4SZIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCOL STEARATE0324G66D0EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
COCO MONOETHANOLAMIDEC80684146DIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9c59151b-2a4e-a008-e053-2a95a90a70d43f235977-62cd-08f5-e054-00144ff8d46c2020-01-17WarningsExact identifier
spl id: 9c59151b-2a4e-a008-e053-2a95a90a70d4
spl set id: 3f235977-62cd-08f5-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.