FDA.reportPublic FDA data

ALEVAI - ANTI DANDRUFF SCALP SERUM

Manufacturer
ALEVAI PRODUCTS LLC
Effective date
2024-11-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:56

Label at a glance#

ProductALEVAI - ANTI DANDRUFF SCALP SERUM
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Indications and uses

For the relief of flaking and itching associated with dandruff.

Dosage and administration

Shake well. Apply and massage directly into affected areas. Can be used in dry or damp hair. Do not Rinse off. For best results, use 1 to 4 times daily or as directed by a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Pyrithione 0.12%

OTC - PURPOSE SECTION

Anti-dandruff

USES:

INDICATIONS & USAGE SECTION

For the relief of flaking and itching associated with dandruff.

WARNINGS SECTION

​For external use only.

OTC - WHEN USING SECTION

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

STOP USE AND ASK DOCTOR IF

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help, or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Shake well. Apply and massage directly into affected areas. Can be used in dry or damp hair. Do not Rinse off. For best results, use 1 to 4 times daily or as directed by a doctor.

INACTIVE INGREDIENT SECTION

Aqua, Polysorbate 20, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glycerin, Urtica Dioica (Nettle) Extract, Betula Alba Bark Extract, Juglans Regia (Walnut) Leaf Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Phenoxyethanol, Sodium Lactate, Sodium Gluconate, Benzyl Alcohol, Benzoic Acid, Sorbic Acid, Xanthan Gum, Aloe Barbadensis Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Allium Sativum Bulb Extract, Rosmarinus Officinalis (Rosemary) Oil, Sodium Hydroxide, Linalool, Limonene.

ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 1 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 30ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 30

ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 2 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 60ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 60

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2634477zinc pyrithione 0.12 % Topical CreamPSN3
2634477zinc pyrithione 1.2 MG/ML Topical CreamSCD3
2634477zinc pyrithione 0.12 % Topical CreamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81457-012-012026-01-29C16284748780-149896155-cc8a-586f-e063-e6dba90add9081457-012-01 81457-012-02
81457-012-022026-01-29C16284748780-149896155-cc8a-586f-e063-e6dba90add9081457-012-01 81457-012-02

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81457-012-01ALEVAI - ANTI DANDRUFF SCALP SERUM30 mL in 1 BOTTLE, DROPPERCREAM303
81457-012-01ALEVAI - ANTI DANDRUFF SCALP SERUM1 in 1 BOXCREAM13
81457-012-02ALEVAI - ANTI DANDRUFF SCALP SERUM60 mL in 1 BOTTLE, DROPPERCREAM603
81457-012-02ALEVAI - ANTI DANDRUFF SCALP SERUM1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81457-012ALEVAI - ANTI DANDRUFF SCALP SERUM (ZINC PYRITHIONE) CREAM [ALEVAI PRODUCTS LLC]34 package rows20241124_f6525731-c6c2-6355-e053-2a95a90a89f4.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81457-01281457-012-01, 81457-012-02

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
SORBIC ACIDX045WJ989BIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
BETULA PUBESCENS BARK3R504894L9IACT
ALLIUM SATIVUM WHOLEIIF21WT8O3IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ROSEMARY OIL8LGU7VM393IACT
LINALOOL, (+/-)-D81QY6I88EIACT
ALOE VERA LEAFZY81Z83H0XIACT
HORSE CHESTNUT3C18L6RJAZIACT
SODIUM LACTATETU7HW0W0QTIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
LAURETH-7Z95S6G8201IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM GLUCONATER6Q3791S76IACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZOIC ACID8SKN0B0MIMIACT
LAVENDER OILZBP1YXW0H8IACT
JUGLANS REGIA LEAF85HKB87105IACT

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
2786d155-45bd-9b62-e063-6394a90aadb3f6525731-c6c2-6355-e053-2a95a90a89f42024-11-22WarningsExact identifier
spl id: 2786d155-45bd-9b62-e063-6394a90aadb3
spl set id: f6525731-c6c2-6355-e053-2a95a90a89f4

Reported adverse events (FAERS/openFDA)#

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