FDA.reportPublic FDA data

PYRITHIONE ZINC

Manufacturer
EROS GLOBAL CORP | CHEMCO CORPORATION
Effective date
2022-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:50:01

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80465-001-10PYRITHIONE ZINC283 g in 1 BOTTLESHAMPOO2833

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80465-001PYRITHIONE ZINC SHAMPOO [EROS GLOBAL CORP]3Legacy NDC, 1 package rows20220701_afd8b1a8-0b56-ec4d-e053-2a95a90a7e4c.zip

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
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
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

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 id: e29650e8-7841-bb71-e053-2a95a90ad0d8
spl set id: afd8b1a8-0b56-ec4d-e053-2a95a90a7e4c

Reported adverse events (FAERS/openFDA)#

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