FDA.reportPublic FDA data

Dermaharmony Face and Body

Manufacturer
D3 Development, Inc. | Vanguard Soap, LLC.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:47:49

Label at a glance#

ProductDermaharmony Face and Body
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

Purpose

Dandruff / Seborrheic dermatitis

INDICATIONS & USAGE SECTION

Uses

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 havea condition that 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 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

  • Use on affected areas in place of your regular soap / shampoo
  • For best results use at least twice a week or as directed by a doctor
  • Rub between hands to create a lather, or apply bar directly onto body / hair
  • Massage into the skin or scalp for 60-90 seconds, then rinse well

STORAGE AND HANDLING SECTION

Other information

  • Store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, coco glucoside, water, soyethyl morpholinium ethosulfate, cetearyl alcohol & ceteareth-20, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, oat (Avena Sativa) flour, sucrose cocoate, olive oil, tocopheryl acetate (vitamin E), sodium isostearoyl lactylate, iron oxides (yellow).

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in USA of U.S. and imported ingredients.

NDC Code: 71819-008-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

Face & Body

with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

Reduces itching-irritation-redness-flaking-scaling

NET WT 4 OZ (113G)

Face-Body-Bar-V3Face-Body-Bar-V3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283707zinc pyrithione 2 % Medicated Bar SoapPSN2
283707zinc pyrithione 0.02 MG/MG Medicated Bar SoapSCD2
283707zinc pyrithione 2 % Medicated Bar SoapSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-008-04Dermaharmony Face and Body113 g in 1 CARTONSOAP1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-008DERMAHARMONY FACE AND BODY (PYRITHIONE ZINC) SOAP [D3 DEVELOPMENT, INC.]2Current NDC, Legacy NDC, 1 package rows20241222_bd72b53c-b22c-40d0-e053-2995a90af9c1.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
71819-00871819-008-04

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
STEARETH-20L0Q8IK9E08IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
DISODIUM 2-SULFOLAURATE329M3829G2IACT
OATMEAL8PI54V663YIACT
ARGAN OIL4V59G5UW9XIACT
WATER059QF0KO0RIACT
SODIUM ISOSTEAROYL LACTYLATE8730J0D3EVIACT
COCO GLUCOSIDEICS790225BIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
STEARIC ACID4ELV7Z65APIACT
COCONUT ACID40U37V505DIACT
SOYETHYL MORPHOLINIUM ETHOSULFATEJ8C5W5HH18IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
OLIVE OIL6UYK2W1W1EIACT
SODIUM METHYL 2-SULFOLAURATEI39GGJ23HVIACT
SODIUM ISETHIONATE3R36J71C17IACT
SUCROSE COCOATE3H18P0UK73IACT
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 Face and BodyPYRITHIONE ZINCD3 Development, Inc.bd72b53c-b22c-40d0-e053-2995a90af9c12024-12-20WarningsExact identifier
ndc (package): 71819-008-04
ndc (product): 71819-008
ndc11 (package): 71819000804
spl id: 29ba89f0-e6fb-0811-e063-6294a90a288c
spl set id: bd72b53c-b22c-40d0-e053-2995a90af9c1

Reported adverse events (FAERS/openFDA)#

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