FDA.reportPublic FDA data

ALEVAI - STEM CELL ANTI DANDRUFF

Manufacturer
ALEVAI PRODUCTS LLC
Effective date
2024-11-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:38:55

Label at a glance#

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Use helps prevent recurrence of flaking and itching associated with dandruff.

INDICATIONS & USAGE SECTION

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Shake well. Wet hair. Massage shampoo into scalp. Rinse. Repeat if desired. For best results, use at least twice a week or as directed by a doctor. For maximum dandruff control, use every time you shampoo.

OTC - STOP USE SECTION

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

INACTIVE INGREDIENT SECTION

Aqua, Sodium C14-16 Olefin Sulfonate, Acrylates Copolymer, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Methyl Gluceth-20, Cocamide MEA, Caprylyl Glycol, Hexylene Glycol, Parfum, Sodium Hydroxide, Polyquaternium-7, Mica, Titanium Dioxide, Silica, Iron Oxide, Tin Oxide, Propylene Glycol, Biotin, Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Sodium Benzoate, Camellia Sinensis Leaf Extract, Disodium EDTA, Hydrolyzed Keratin, Citric Acid, Panthenol, Argania Spinosa Kernel Oil, Cocos Nucifera Oil, Phenoxyethanol, FD&C Blue. 1 (CI 42090), Hexyl Cinnamal, Citral.

ALEVAI - ANTI DANDRUFF SHAMPOO 3.4OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVAI - ANTI DANDRUFF SHAMPOO 3.4OZALEVAI - ANTI DANDRUFF SHAMPOO 3.4OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 8OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVAI - ANTI DANDRUFF SHAMPOO 8OZALEVAI - ANTI DANDRUFF SHAMPOO 8OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 16OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVAI - ANTI DANDRUFF SHAMPOO 16OZALEVAI - ANTI DANDRUFF SHAMPOO 16OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 32OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVAI - ANTI DANDRUFF SHAMPOO 32OZALEVAI - ANTI DANDRUFF SHAMPOO 32OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244458zinc pyrithione 2 % Medicated ShampooPSN7
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD7
244458zinc pyrithione 2 % Medicated ShampooSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81457-020-04ALEVAI - STEM CELL ANTI DANDRUFF96 g in 1 BOTTLESHAMPOO967
81457-020-08ALEVAI - STEM CELL ANTI DANDRUFF226 g in 1 BOTTLESHAMPOO2267
81457-020-16ALEVAI - STEM CELL ANTI DANDRUFF453 g in 1 BOTTLESHAMPOO4537
81457-020-32ALEVAI - STEM CELL ANTI DANDRUFF906 g in 1 BOTTLESHAMPOO9067

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81457-020ALEVAI - STEM CELL ANTI DANDRUFF (PYRITHIONE ZINC) SHAMPOO [ALEVAI PRODUCTS LLC]7Legacy NDC, 4 package rows20241124_d09b2fb8-c252-67b8-e053-2995a90a377a.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81457-02081457-020-08, 81457-020-16, 81457-020-04, 81457-020-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCO MONOETHANOLAMIDEC80684146DIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
STANNIC OXIDEKM7N50LOS6IACT
ARGANIA SPINOSA WHOLE83K6O4FR76IACT
XANTHAN GUMTTV12P4NEEIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PANTHENOLWV9CM0O67ZIACT
COCOS NUCIFERA WHOLE245J88W96LIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
METHYL GLUCETH-20J3QD0LD11PIACT
BIOTIN6SO6U10H04IACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM BENZOATEOJ245FE5EUIACT
MALUS DOMESTICA WHOLE04W636S1V3IACT
EDETATE DISODIUM7FLD91C86KIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
27868835-97be-3d3d-e063-6394a90a1978d09b2fb8-c252-67b8-e053-2995a90a377a2024-11-22WarningsExact identifier
spl id: 27868835-97be-3d3d-e063-6394a90a1978
spl set id: d09b2fb8-c252-67b8-e053-2995a90a377a

Reported adverse events (FAERS/openFDA)#

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