FDA.reportPublic FDA data

Satinique Anti Dandruff

Manufacturer
Access Business Group LLC
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:57:21

Label at a glance#

ProductSatinique Anti Dandruff
Active ingredientPYRITHIONE ZINC
Label structure6 sections

Indications and uses

Controls symptoms of dandruff

Dosage and administration

Shake well before use. Wet hair. Apply shampoo and work into a lather. Rinse thoroughly. For best result, use at least twice a week or as directed by a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 0.95%

Purpose

OTC - PURPOSE SECTION

Anti Dandruff

Uses

INDICATIONS & USAGE SECTION

  • Controls symptoms of dandruff

Warnings

WARNINGS SECTION

For external use only.

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

or does not improve after regular use, consult a doctor. If condition worsens

Keep out of reach of children.

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 before use.
  • Wet hair. Apply shampoo and work into a lather. Rinse thoroughly.
  • For best result, use at least twice a week or as directed by a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Decyl Glucoside, Glycol Distearate, Disodium Laureth Sulfosuccinate, Glycereth-26, Ceramide 2 , Ceramide-3, C10-40 isoalkylamidopropylethyldimonium ethosulfate, Creatine, Fragrance, Dimethicome, Sodium Chloride, C12-15 Alkyl Lactate, Hydroxypropyl Methylcellulose, Guar Hydroxypropyltrimonium Chloride, Zinc Chloride, Hectorite, Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Tocopheryl Acetate, Limnanthes Alba (Meadowfoam) Seed Oil, Propylene Glycol, Aloe Barbadensis Leaf Juice, Butyl Avodate, PPG-12-Buteth-15, Triethanolamine, Sodium PCA, Sodium Lactate, Arginine, Aspartic Acid, PCA, Glycine, Alanine, MethylChlororisothiazolinone, Serine, Valine, Behenic Acid, Cholesterol, Isoleucine, Proline, Threonine, Methylisothiazolinone, Histidine, Phenylalanine, Perilla Ocymoides Leaf Extract, Green 3, Blue 1.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1091088zinc pyrithione 0.95 % Medicated ShampooPSN6
1091088zinc pyrithione 9.5 MG/ML Medicated ShampooSCD6
1091088zinc pyrithione 0.95 % Medicated ShampooSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10056-006-012021-10-26C16284748780-1ba0f9c33-4cb8-a910-e053-dadaa90a0b85Satinique Anti-Dandruff shampoo
10056-006-012021-01-29C16284748780-1ba0f9c33-4cb8-a910-e053-dadaa90a0b85Satinique Anti-Dandruff shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10056-006-01Satinique Anti Dandruff280 mL in 1 BOTTLECREAM2806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10056-006SATINIQUE ANTI DANDRUFF (PYRITHIONE ZINC) CREAM [ACCESS BUSINESS GROUP LLC]6Current NDC, Legacy NDC, 1 package rows20231023_ae71967e-110d-4fae-a966-8382ca62bc1f.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10056-00610056-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
GLYCOL DISTEARATE13W7MDN21WIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
GLYCERETH-26NNE56F2N14IACT
CERAMIDE 2C04977SRJ5IACT
CERAMIDE 34370DF050BIACT
CREATINEMU72812GK0IACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM CHLORIDE451W47IQ8XIACT
C12-15 ALKYL LACTATEGC844VRD7EIACT
HYPROMELLOSES3NXW29V3WOIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
ZINC CHLORIDE86Q357L16BIACT
HECTORITE08X4KI73EZIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
PPG-12-BUTETH-1658CG7042J1IACT
TROLAMINE9O3K93S3TKIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
SODIUM LACTATETU7HW0W0QTIACT
ARGININE94ZLA3W45FIACT
ASPARTIC ACID30KYC7MIAIIACT
PIDOLIC ACIDSZB83O1W42IACT
GLYCINETE7660XO1CIACT
ALANINEOF5P57N2ZXIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
SERINE452VLY9402IACT
VALINEHG18B9YRS7IACT
BEHENIC ACIDH390488X0AIACT
CHOLESTEROL97C5T2UQ7JIACT
ISOLEUCINE04Y7590D77IACT
PROLINE9DLQ4CIU6VIACT
THREONINE2ZD004190SIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

Source Document#

Source XML · Source PDF

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
Satinique Anti DandruffPYRITHIONE ZINCAccess Business Group LLCae71967e-110d-4fae-a966-8382ca62bc1f2023-10-23WarningsExact identifier
ndc (package): 10056-006-01
ndc (product): 10056-006
ndc11 (package): 10056000601
spl id: 085bb064-0a35-cb0d-e063-6294a90a16a1
spl set id: ae71967e-110d-4fae-a966-8382ca62bc1f

Reported adverse events (FAERS/openFDA)#

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