FDA.reportPublic FDA data

Dermaharmony Bar

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 00:47:41

Label at a glance#

ProductDermaharmony Bar Peppermint
Active ingredientPYRITHIONE ZINC
Label structure15 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 shampoo

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 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 shampoo
  • For best results use at least twice a week or as directed by a doctor
  • Rub between hands to create a lather, or directly onto hair. Massage into the hair and scalp then rinse.

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, peppermint (Mentha Piperita) oil, 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, sodium isostearoyl lactylate, iron oxides (ochre).

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc. (DBA DermaHarmony), Portland, ME 04101

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

NDC Code: 71819-005-45

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

PEPPERMINT

Shampoo Bar with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

NET WT 4.5 OZ (128 G)

Dandruff-Shampoo-Bar 20-03-30Dandruff-Shampoo-Bar 20-03-30

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283707zinc pyrithione 2 % Medicated Bar SoapPSN3
283707zinc pyrithione 0.02 MG/MG Medicated Bar SoapSCD3
283707zinc pyrithione 2 % Medicated Bar SoapSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-005-04Dermaharmony BarPeppermint113 g in 1 CARTONSHAMPOO1133
71819-005-45Dermaharmony BarPeppermint128 g in 1 CARTONSHAMPOO1283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-005DERMAHARMONY BAR PEPPERMINT (PYRITHIONE ZINC) SHAMPOO [D3 DEVELOPMENT, INC.]3Current NDC, Legacy NDC, 2 package rows20241222_a19b74b0-88c6-6897-e053-2a95a90a7309.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
71819-00571819-005-45, 71819-005-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BROWN IRON OXIDE1N032N7MFOIACT
DISODIUM 2-SULFOLAURATE329M3829G2IACT
OATMEAL8PI54V663YIACT
ARGAN OIL4V59G5UW9XIACT
WATER059QF0KO0RIACT
SODIUM ISOSTEAROYL LACTYLATE8730J0D3EVIACT
COCO GLUCOSIDEICS790225BIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
STEARIC ACID4ELV7Z65APIACT
COCONUT ACID40U37V505DIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
SOYETHYL MORPHOLINIUM ETHOSULFATEJ8C5W5HH18IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PEPPERMINT OILAV092KU4JHIACT
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 Bar PeppermintPYRITHIONE ZINCD3 Development, Inc.a19b74b0-88c6-6897-e053-2a95a90a73092024-12-20WarningsExact identifier
ndc (package): 71819-005-04
ndc (package): 71819-005-45
ndc (product): 71819-005
ndc11 (package): 71819000545
ndc11 (package): 71819000504
spl id: 29ba89f0-e6e7-0811-e063-6294a90a288c
spl set id: a19b74b0-88c6-6897-e053-2a95a90a7309

Reported adverse events (FAERS/openFDA)#

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