FDA.reportPublic FDA data

Dermaharmony Sulfur and Salicylic Acid

Manufacturer
D3 Development, Inc. | Vanguard Soap, LLC.
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:19:26

Label at a glance#

ProductDermaharmony Sulfur and Salicylic Acid
Active ingredientSULFUR, SALICYLIC ACID
Label structure15 sections

Storage and handling

Other information Store at 59° to 77°F (15° to 25°C) Lot number and expiration date are printed on back panel

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Salicylic acid 2%

Sulfur 5%

OTC - PURPOSE SECTION

Purpose

Dandruff / sebhorreic dermatitis / psoriasis soap

INDICATIONS & USAGE SECTION

Uses

​Helps prevent and control recurrence of itching, flaking and irritation associated with 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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.
  • Work up a lather using warm water and massage into affected areas.
  • Rinse.

STORAGE AND HANDLING SECTION

Other information

  • Store at 59° to 77°F (15° to 25°C)
  • Lot number and expiration date are printed on back panel

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, soyethyl morpholinium ethosulfate (soy derived), sodium chloride, pentasodium pentetate

*May contain this ingredient

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

5% Sulfur & 2% Salicylic Acid SOAP

For Dandruff, Sebhorreic Dermatitis & Psoriasis

NET WT 4 OZ (113 G)

image of cartonimage of cartonImage of labelImage of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2177191salicylic acid 2 % / sulfur 5 % Medicated Bar SoapPSN3
2177191salicylic acid 0.02 MG/MG / sulfur 0.05 MG/MG Medicated Bar SoapSCD3
2177191salicylic acid 2 % / sulfur 5 % Medicated Bar SoapSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810103240087GTIN-13: 0810103240087
EAN-13: 0810103240087
GTIN-12: 810103240087
UPC-A: 810103240087
GTIN storage (14 digits): 00810103240087		SulfurSA Soap Carton.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-004-04Dermaharmony Sulfur and Salicylic Acid113 g in 1 CELLO PACKSOAP1133
71819-004-05Dermaharmony Sulfur and Salicylic Acid113 g in 1 CELLO PACKSOAP1133

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71819-00471819-004-04, 71819-004-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
SODIUM COCOATER1TQH25F4IIACT
GLYCERINPDC6A3C0OXIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
SODIUM PALMATES0A6004K3ZIACT
SOYETHYL MORPHOLINIUM ETHOSULFATEJ8C5W5HH18IACT
PENTASODIUM PENTETATE961TOZ5L7TIACT
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 Sulfur and Salicylic AcidSALICYLIC ACID, SULFURD3 Development, Inc.8cb1d526-1ba7-6b02-e053-2a95a90aa1d02025-12-02WarningsExact identifier
ndc (package): 71819-004-05
ndc (package): 71819-004-04
ndc (product): 71819-004
ndc11 (package): 71819000405
ndc11 (package): 71819000404
spl id: 44fcc5ef-5c27-35e3-e063-6294a90af66a
spl set id: 8cb1d526-1ba7-6b02-e053-2a95a90aa1d0

Reported adverse events (FAERS/openFDA)#

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