FDA.reportPublic FDA data

Pyrithione Zinc

Manufacturer
ALEVAI PRODUCTS LLC | CHEMCO CORPORATION
Effective date
2022-07-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:53:39

Label at a glance#

ProductALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER
Active ingredientPYRITHIONE ZINC
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc………………………………………………………………………………………. 2% Anti-dandruff

OTC - PURPOSE SECTION

For the relief of the symptoms of dandruff and seborrheic dermatitis

INDICATIONS & USAGE SECTION

Do not get into eyes. If contact occurs rinse eyes thoroughly with water.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Do not get into eyes. If contact occurs rinse eyes thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP out of the reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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

Apply a small amount quantity of the product into hair and massage the scalp.

Allow the product to act for 5 minutes.

Rinse thoroughly with water.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if conditions worsen or does not improve after regular use as directed.

INACTIVE INGREDIENT SECTION

Aqua, Cetearyl Alcohol, Behentrimonium Methosulfate, Stearyl Alcohol, Cetyl Alcohol, Caprylic/Capric Triglyceride, Chlorophenesin, Caprylyl Glycol, Parfum, Organic Butyrospermum Parkii (Shea) Butter, Panthenol, Hydrolyzed Keratin, Hydroxypropyl Guar, Ricinus Communis (Castor) Seed Oil, Disodium EDTA, Propylene Glycol, Biotin, Argania Spinosa Kernel Oil, Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Sodium Benzoate, Glycerin, Algae Extract, Citric Acid, Phenoxyethanol, Cetrimonium Chloride, Hexyl Cinnamal, Citral.

ALEVAI - ANTI DANDRUFF CONDITIONER 3.4OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVAI - ANTI DANDRUFF CONDITIONER 3.4OZALEVAI - ANTI DANDRUFF CONDITIONER 3.4OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 8OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVAI - ANTI DANDRUFF CONDITIONER 8OZALEVAI - ANTI DANDRUFF CONDITIONER 8OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 16OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVAI - ANTI DANDRUFF CONDITIONER 16OZALEVAI - ANTI DANDRUFF CONDITIONER 16OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 32OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVAI - ANTI DANDRUFF CONDITIONER 32OZALEVAI - ANTI DANDRUFF CONDITIONER 32OZ

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81457-002-042025-01-30C16284748780-12cef2736-9410-d83d-e063-dadaa90ab31f81457-002-04 81457-002-08 81457-002-16 81457-002-32
81457-002-082025-01-30C16284748780-12cef2736-9410-d83d-e063-dadaa90ab31f81457-002-04 81457-002-08 81457-002-16 81457-002-32
81457-002-162025-01-30C16284748780-12cef2736-9410-d83d-e063-dadaa90ab31f81457-002-04 81457-002-08 81457-002-16 81457-002-32
81457-002-322025-01-30C16284748780-12cef2736-9410-d83d-e063-dadaa90ab31f81457-002-04 81457-002-08 81457-002-16 81457-002-32

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81457-002-04ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER100 mL in 1 BOTTLELOTION1006
81457-002-08ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER236 mL in 1 BOTTLELOTION2366
81457-002-16ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER473 mL in 1 BOTTLELOTION4736
81457-002-32ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER946 mL in 1 BOTTLELOTION9466

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81457-002ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER (PYRITHIONE ZINC) LOTION [ALEVAI PRODUCTS LLC]6Legacy NDC, 4 package rows20230202_d0eebc4c-5558-3332-e053-2995a90a5e96.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81457-00281457-002-08, 81457-002-16, 81457-002-04, 81457-002-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
SHEA BUTTERK49155WL9YIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)3A1I7376TCIACT
SODIUM BENZOATEOJ245FE5EUIACT
CETYL ALCOHOL936JST6JCNIACT
RICINUS COMMUNIS SEED7EK4SFN1TXIACT
BIOTIN6SO6U10H04IACT
ARGANIA SPINOSA WHOLE83K6O4FR76IACT
MALUS DOMESTICA WHOLE04W636S1V3IACT
PANTHENOLWV9CM0O67ZIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
CHLORPHENESINI670DAL4SZIACT
EDETATE DISODIUM7FLD91C86KIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

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
e3c449cf-60b4-22f6-e053-2a95a90af0f9d0eebc4c-5558-3332-e053-2995a90a5e962022-07-14WarningsExact identifier
spl id: e3c449cf-60b4-22f6-e053-2a95a90af0f9
spl set id: d0eebc4c-5558-3332-e053-2995a90a5e96

Reported adverse events (FAERS/openFDA)#

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