FDA.reportPublic FDA data

Seborrheic Dermatitis Cream

Manufacturer
D3 Development, Inc. | Vanguard Soap, LLC.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:47:37

Label at a glance#

ProductDermaharmony Seborrheic Dermatitis
Active ingredientPYRITHIONE ZINC
Label structure15 sections

Storage and handling

Other information Store at 59° to 77°F (15° to 25°C) Lot number and expiration date can be found on lid.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Pyrithione zinc 0.25%

OTC - PURPOSE SECTION

Purpose

Seborrheic dermatitis cream

INDICATIONS & USAGE SECTION

Uses

  • Relieves skin and/or scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis
  • Helps eliminate recurrence of seborrheic dermatitis

WARNINGS SECTION

Warnings

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use ifcondition covers a large area of the body.

OTC - WHEN USING SECTION

When using this productavoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor ifcondition worsens or does not improve after regular use of the 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

Apply to affected area one to four times daily

STORAGE AND HANDLING SECTION

Other information

  • Store at 59° to 77°F (15° to 25°C)
  • Lot number and expiration date can be found on lid.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, prunus amygdalus dulcis (sweet almond) oil, persea gratissima (avocado) oil, behentrimonium methosulfate, cetyl alcohol, glycerin, coco nucifera (coconut) oil, ricinus communis (castor) oil, stearyl alcohol, beeswax, shea butter, mango seed butter, phenoxyethanol, caprylyl glycol, tocopherol (vitamin E), hydroxyethylcellulose

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc.

Portland, ME 04101

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

Seborrheic Dermatitis CREAM

Contains 0.25% Pyrithione Zinc

3 FL OZ (89 ml)

Seb Derm Cream FINALSeb Derm Cream FINAL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259549zinc pyrithione 0.25 % Topical CreamPSN3
259549zinc pyrithione 2.5 MG/ML Topical CreamSCD3
259549zinc pyrithione 0.25 % Topical CreamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-002-03Dermaharmony Seborrheic Dermatitis89 mL in 1 BOTTLE, PLASTICCREAM893
71819-002-06Dermaharmony Seborrheic Dermatitis177 mL in 1 BOTTLE, PLASTICCREAM1773
71819-002-08Dermaharmony Seborrheic Dermatitis237 mL in 1 BOTTLE, PLASTICCREAM2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-002DERMAHARMONY SEBORRHEIC DERMATITIS (PYRITHIONE ZINC) CREAM [D3 DEVELOPMENT, INC.]3Current NDC, Legacy NDC, 3 package rows20241222_8d81521d-9e6f-1acf-e053-2995a90a9242.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71819-00271819-002-03, 71819-002-06, 71819-002-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
HYDROXYETHYL CELLULOSE (1800 MPA.S AT 2%)6OX6A5C7B6IACT
STEARYL ALCOHOL2KR89I4H1YIACT
ALMOND OIL66YXD4DKO9IACT
WATER059QF0KO0RIACT
AVOCADO OIL6VNO72PFC1IACT
CETYL ALCOHOL936JST6JCNIACT
COCONUT OILQ9L0O73W7LIACT
CASTOR OILD5340Y2I9GIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
SHEA BUTTERK49155WL9YIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
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
Dermaharmony Seborrheic DermatitisPYRITHIONE ZINCD3 Development, Inc.8d81521d-9e6f-1acf-e053-2995a90a92422024-12-20WarningsExact identifier
ndc (package): 71819-002-06
ndc (package): 71819-002-03
ndc (package): 71819-002-08
ndc (product): 71819-002
ndc11 (package): 71819000206
ndc11 (package): 71819000203
ndc11 (package): 71819000208
spl id: 29ba17fa-1175-3c2b-e063-6394a90a0d4c
spl set id: 8d81521d-9e6f-1acf-e053-2995a90a9242

Reported adverse events (FAERS/openFDA)#

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