FDA.reportPublic FDA data

80465-001-10

Manufacturer
EROS GLOBAL CORP | CHEMCO CORPORATION
Effective date
2026-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-27 02:02:26

Label at a glance#

ProductPYRITHIONE ZINC
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

For maximum dandruff control, use every time you shampoo.
Wet hair, massage unto scalp, rinse, and repeat if desired.

For best results use at least twice a week or as directed by a doctor.

WARNINGS SECTION

For external use only. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

INACTIVE INGREDIENT SECTION

Aqua, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Cocoamide DEA, Acrylates/Steareth-20 Methacrylate Copolymer, Propylene Glycol, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Methylparaben, Propylparaben, Parfum, Polyquaternium-7, Phosphoric Acid, FD&C Blue 1/ CI 42090, Limonene.

INDICATIONS & USAGE SECTION

Anti-Dandruff Shampoo Helps prevent recurrence of flaking and itching associated with dandruff.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of children’s reach.

OTC - PURPOSE SECTION

Anti-dandruff

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 OZ10 OZ

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80465-001-102024-01-30C16284748780-11030e365-1cab-111a-e063-dadaa90a10e280465-001-10
80465-001-102024-01-30C16284748780-11030e365-1cab-111a-e063-dadaa90a10e280465-001-10

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80465-00180465-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMEREPA1872R1NIACT
DMDM HYDANTOINBYR0546TOWIACT
PROPYLPARABENZ8IX2SC1OHIACT
PHOSPHORIC ACIDE4GA8884NNIACT
LIMONENE, (+/-)-9MC3I34447IACT
BASIC BLUE 192N74OA24DIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM LAURYL SULFATE368GB5141JIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32022-06-29full-release2026-05-31 23:50:01

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
e29650e8-7841-bb71-e053-2a95a90ad0d8afd8b1a8-0b56-ec4d-e053-2a95a90a7e4c2022-06-29WarningsExact identifier
spl set id: afd8b1a8-0b56-ec4d-e053-2a95a90a7e4c

Reported adverse events (FAERS/openFDA)#

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