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
2
Source
full-release
Hydrated at
2026-06-01 00:47:46

Label at a glance#

ProductDermaharmony Bar Peppermint
Active ingredientSULFUR, SALICYLIC ACID
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

Salicylic Acid 2%

Sulfur 5%

OTC - PURPOSE SECTION

Purpose

Dandruff / sebhorreic dermatitis / psoriasis shampoo

INDICATIONS & USAGE SECTION

Uses

​Helps stop the symptoms of dandruff, sebhorreic dermatitis, and psoriasis.

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 product,avoid 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 apply bar directly onto hair
  • Massage into the hair and 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, peppermint (Mentha Piperita) oil, coco glucoside, water, sodium methyl 2 sulfolaurate & disodium-2-sulfolaurate, cetearyl alcohol & ceteareth-20, tetrasodium glutamate diacetate, argan oil, oat (Avena Sativa) flour, sucrose cocoate, sodium isostearoyl lactylate

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in USA of U.S. and imported ingredients

NDC 71819-009-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

PEPPERMINT

Shampoo Barwith Sulfur & Salicylic Acid

FOR DANDRUFF, SEBORRHEIC DERMATITIS & PSORIASIS

NET WT 4 OZ (113 G)

71819-009-0471819-009-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2177191salicylic acid 2 % / sulfur 5 % Medicated Bar SoapPSN2
2177191salicylic acid 0.02 MG/MG / sulfur 0.05 MG/MG Medicated Bar SoapSCD2
2177191salicylic acid 2 % / sulfur 5 % Medicated Bar SoapSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-009-04Dermaharmony BarPeppermint113 g in 1 CARTONSHAMPOO1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-009DERMAHARMONY BAR PEPPERMINT (SALICYLIC ACID, SULFUR) SHAMPOO [D3 DEVELOPMENT, INC.]2Current NDC, Legacy NDC, 1 package rows20241222_af7060a9-986c-500e-e053-2a95a90a6438.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
71819-00971819-009-04

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
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
ARGAN OIL4V59G5UW9XIACT
SODIUM ISETHIONATE3R36J71C17IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
COCONUT ACID40U37V505DIACT
PEPPERMINT OILAV092KU4JHIACT
COCO GLUCOSIDEICS790225BIACT
SODIUM METHYL 2-SULFOLAURATEI39GGJ23HVIACT
DISODIUM 2-SULFOLAURATE329M3829G2IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
OATMEAL8PI54V663YIACT
SODIUM ISOSTEAROYL LACTYLATE8730J0D3EVIACT
SUCROSE COCOATE3H18P0UK73IACT
STEARIC ACID4ELV7Z65APIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
SULFUR70FD1KFU70ACTIB
SALICYLIC ACIDO414PZ4LPZACTIB

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 PeppermintSALICYLIC ACID, SULFURD3 Development, Inc.af7060a9-986c-500e-e053-2a95a90a64382024-12-20WarningsExact identifier
ndc (package): 71819-009-04
ndc (product): 71819-009
ndc11 (package): 71819000904
spl id: 29ba86b1-f660-482e-e063-6394a90a931f
spl set id: af7060a9-986c-500e-e053-2a95a90a6438

Reported adverse events (FAERS/openFDA)#

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