FDA.reportPublic FDA data

ADVANCED SEBORRHEIC DERMATITIS THERAPY

Manufacturer
CVS Pharmacy, Inc.
Effective date
2016-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:17

Label at a glance#

ProductADVANCED SEBORRHEIC DERMATITIS THERAPY
Active ingredientPYRITHIONE ZINC
Label structure12 sections

Dosage and administration

■ Use on affected areas in place of your regular soap ■ For best results use at least twice a week or as directed by a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 2%

Purpose

OTC - PURPOSE SECTION

Dandruff/Seborrheic Dermatitis

Use

INDICATIONS & USAGE SECTION

For relief of skin itching, flaking, and scaling associated with dandruff and seborrheic dermatitis

Warnings

WARNINGS SECTION

For external use only

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use on affected areas in place of your regular soap
■ For best results use at least twice a week or as directed by a doctor

When using this product

OTC - WHEN USING SECTION

■ avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

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

Ask a doctor before use

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have seborrheic dermatitis that covers a large portion of the body.

INACTIVE INGREDIENT SECTION

Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Palmitic Acid, Titanium Dioxide (CI 77891), Sodium Chloride, Jojoba Esters, Tetrasodium EDTA, Tetrasodium Etidronate, Iron Oxides (CI 77499), Ferric Ferrocyanide, Green 5 (CI 61570),
Yellow 10 (CI 47005)

Questions?

OTC - QUESTIONS SECTION

www.CVS.com

1-800-SHOP CVS

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283707zinc pyrithione 2 % Medicated Bar SoapPSN1
283707zinc pyrithione 0.02 MG/MG Medicated Bar SoapSCD1
283707zinc pyrithione 2 % Medicated Bar SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-343-782023-01-30C16284748780-1f386c649-ab5d-0266-e053-dadaa90a7c1aADVANCED SEBORRHEIC DERMATITIS THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-343-78ADVANCED SEBORRHEIC DERMATITIS THERAPY119 g in 1 BOXSOAP1191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-343ADVANCED SEBORRHEIC DERMATITIS THERAPY (PYRITHIONE ZINC) SOAP [CVS PHARMACY, INC.]1Legacy NDC, 1 package rows20160615_354460ae-f367-3803-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-34369842-343-78

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
SODIUM PALMATES0A6004K3ZIACT
PALMITIC ACID2V16EO95H1IACT
GLYCERINPDC6A3C0OXIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
ETIDRONATE TETRASODIUMCZZ9T1T1X4IACT
EDETATE SODIUMMP1J8420LUIACT
HYDROGENATED JOJOBA OIL7F674YQ5SOIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC FERROCYANIDETLE294X33AIACT
FERROUS OXIDEG7036X8B5HIACT
D&C GREEN NO. 58J6RDU8L9XIACT
D&C YELLOW NO. 1035SW5USQ3GIACT

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
35446d0a-1f90-3a03-e054-00144ff88e88354460ae-f367-3803-e054-00144ff88e882016-06-14WarningsExact identifier
spl id: 35446d0a-1f90-3a03-e054-00144ff88e88
spl set id: 354460ae-f367-3803-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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