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 Leave-In Treatment Step 3
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 0.22%

Purpose

OTC - PURPOSE SECTION

Antidandruff

Indications

INDICATIONS & USAGE SECTION

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

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
  • 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 INGREDIENT SECTION

Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetrimonium Bromide, Cetyl Alcohol, Chlorphenesin, Disodium EDTA, Elaeis Guineensis (Palm) Oil, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Stearyl Dihydroxypropyldimonium Oligosaccharides, Water, may contain Citric Acid, may contain Sodium Hydroxide

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 Leave-In Treatment Step 3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0243-32024-01-30C16284748780-11030e365-6643-111a-e063-dadaa90a10e2Australian Gold Metro 365 Medicated Leave In Treatment Step 3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0243-3Australian GoldMetro 365 Medicated Leave-In Treatment Step 3118 mL in 1 TUBECREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0243AUSTRALIAN GOLD METRO 365 MEDICATED LEAVE-IN TREATMENT STEP 3 (PYRITHIONE ZINC 0.22%) CREAM [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200118_405720c0-99c1-1d6d-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-024358443-0243-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENESINI670DAL4SZIACT
CETRIMONIUM BROMIDEL64N7M9BWRIACT
PALM OIL5QUO05548ZIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
CETYL ALCOHOL936JST6JCNIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
9c581a78-2937-6be9-e053-2a95a90a778d405720c0-99c1-1d6d-e054-00144ff8d46c2020-01-17WarningsExact identifier
spl id: 9c581a78-2937-6be9-e053-2a95a90a778d
spl set id: 405720c0-99c1-1d6d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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