FDA.reportPublic FDA data

Sebastian Purist Antidandruff

Manufacturer
THE WELLA CORPORATION | COTY US LLC
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:45:20

Label at a glance#

ProductSebastian Purist Antidandruff
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

Helps prevent recurrence of flaking and itching associated with dandruff

Dosage and administration

For best results use at least twice a week or as directed by a doctor.Apply a small amount evenly over wet scalp and hair. Leave on for several minutes. Rinse well.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

Helps prevent recurrence of flaking and itching associated with dandruff

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For best results use at least twice a week or as directed by a doctor.Apply a small amount evenly over wet scalp and hair. Leave on for several minutes. Rinse well.

Inactive ingredients

INACTIVE INGREDIENT SECTION

inactive ingredsinactive ingreds

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-935-5273

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEB

MAN.

THE PURIST

ANTI-DANDRUFF SHAMPOO

PYRITHIONE ZINC

+Guanana

PROFESSIONAL

SEBASTIAN

250 mL (8.4 FL OZ)

frontfront112233

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69282-008-102022-12-22C16284748780-1e4f33bdf-a04d-d8a0-e053-dadaa90a6e4eSebastian Purist Antidandruff Shampoo
69282-008-102022-07-29C16284748780-1e4f33bdf-a04d-d8a0-e053-dadaa90a6e4eSebastian Purist Antidandruff Shampoo

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69282-00869282-008-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAFFEINE3G6A5W338EIACT
DMDM HYDANTOINBYR0546TOWIACT
PROPYLPARABENZ8IX2SC1OHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM SULFITEVTK01UQK3GIACT
PEG-3 DISTEARATE8420ECX438IACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH-8 SULFATEYP8U3694P0IACT
SODIUM HYDROXIDE55X04QC32IIACT
ALLANTOIN344S277G0ZIACT
METHYLPARABENA2I8C7HI9TIACT
MAGNESIUM LAURETH SULFATEUKW9G007TZIACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PANTHENOLWV9CM0O67ZIACT
MAGNESIUM LAURETH-8 SULFATE2OTJ9LF5UAIACT
SODIUM BENZOATEOJ245FE5EUIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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
297ec005-57e9-e657-e063-6394a90aded78c52b468-313c-87a9-e053-2995a90aa81c2024-12-17WarningsExact identifier
spl id: 297ec005-57e9-e657-e063-6394a90aded7
spl set id: 8c52b468-313c-87a9-e053-2995a90aa81c

Reported adverse events (FAERS/openFDA)#

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