FDA.reportPublic FDA data

Vanicream

Manufacturer
Pharmaceutical Specialties, Inc.
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:34

Label at a glance#

ProductVanicream
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Storage and handling

Other information Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Pyrithione zinc 2%

OTC - PURPOSE SECTION

Purposes

Anti-dandruff,

Anti-seborrheic dermatitis

INDICATIONS & USAGE SECTION

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis

WARNINGS SECTION

Warnings

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a condition that covers a large area of the body.

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

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

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

Directions

  • For best results use at least twice a week or as directed by a doctor
  • Shake before use
  • Wet hair and massage gently into scalp
  • Leave lather on scalp for several minutes
  • Rinse well, repeat if needed

STORAGE AND HANDLING SECTION

Other information

Store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredientswater, lauryl glucoside, coco-glucoside, acrylates copolymer, panthenol, pentylene glycol, glycerin, sucrose cocoate, disodium cocoyl glutamate, sodium cocoyl glycinate, behenyl alcohol, sucrose stearate, cetyl palmitate, sodium cocoyl glutamate, 1,2-hexanediol, sodium hydroxide, caprylyl glycol, sodium chloride

SPL UNCLASSIFIED SECTION

Dist. by

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901

1-800-325-8232

Made in USA with select US and imported materials

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45334-206-08

VANICREAM™

Pyrithione Zinc 2%

Dandruff Shampoo

for Sensitive Skin

DERMATOLOGIST TESTED

Free of dyes, fragrance, masking fragrance, lanolin, protein, parabens, & formaldehyde releasers

Sulfate-free • Betaine-free • Gluten-free

8 fl oz (237 mL)

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244458zinc pyrithione 2 % Medicated ShampooPSN3
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD3
244458zinc pyrithione 2 % Medicated ShampooSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45334-206-07Vanicream7.4 mL in 1 TUBESHAMPOO7.43
45334-206-08Vanicream237 mL in 1 BOTTLE, PLASTICSHAMPOO2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45334-206VANICREAM (PYRITHIONE ZINC) SHAMPOO [PHARMACEUTICAL SPECIALTIES, INC.]3Current NDC, Legacy NDC, 2 package rows20241215_d124a093-f739-0666-e053-2995a90a52ed.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45334-20645334-206-08, 45334-206-07

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
1,2-HEXANEDIOLTR046Y3K1GIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
SUCROSE COCOATE3H18P0UK73IACT
SUCROSE STEARATE274KW0O50MIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCO GLUCOSIDEICS790225BIACT
SODIUM COCOYL GLYCINATEXLU9KH03XMIACT
WATER059QF0KO0RIACT
DOCOSANOL9G1OE216XYIACT
PENTYLENE GLYCOL50C1307PZGIACT
GLYCERINPDC6A3C0OXIACT
DEXPANTHENOL1O6C93RI7ZIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
DISODIUM COCOYL GLUTAMATEMBK0CP8F5AIACT
CETYL PALMITATE5ZA2S6B08XIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM CHLORIDE451W47IQ8XIACT
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
VanicreamPYRITHIONE ZINCPharmaceutical Specialties, Inc.d124a093-f739-0666-e053-2995a90a52ed2024-11-27WarningsExact identifier
ndc (package): 45334-206-08
ndc (package): 45334-206-07
ndc (product): 45334-206
ndc11 (package): 45334020607
ndc11 (package): 45334020608
spl id: 27eab869-7131-aed3-e063-6394a90adcb3
spl set id: d124a093-f739-0666-e053-2995a90a52ed

Reported adverse events (FAERS/openFDA)#

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