FDA.reportPublic FDA data

Dermaharmony Sulfur and Salicylic Acid

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 00:47:41

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/expiration date are printed on bottom of this bottle.

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 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 or shampoo.
  • 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/expiration date are printed on bottom of this bottle.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Potassium Cocoate, Potassium Oleate, Potassium Olivate, Sodium Acrylates / Beheneth-25 Methacrylate Crosspolymers, Pumice, Glycerin, Acrylates Copolymer, Citric Acid

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

Sulfur & Salicylic Acid SOAP

For Dandruff, Sebhorreic Dermatitis & Psoriasis

MEDICATED NATURAL CASTILE SOAP

4 FL OZ (118 ml)

Sulf - SA Liq Soap 71819-006Sulf - SA Liq Soap 71819-006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286294salicylic acid 2 % / sulfur 5 % Medicated Liquid SoapPSN2
2286294salicylic acid 20 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCD2
2286294salicylic acid 2 % / sulfur 5 % Medicated Liquid SoapSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-006-04Dermaharmony Sulfur and Salicylic Acid118 mL in 1 BOTTLE, PLASTICLIQUID1182
71819-006-10Dermaharmony Sulfur and Salicylic Acid296 mL in 1 BOTTLE, PLASTICLIQUID2962
71819-006-12Dermaharmony Sulfur and Salicylic Acid355 mL in 1 BOTTLE, PLASTICLIQUID3552
71819-006-64Dermaharmony Sulfur and Salicylic Acid1893 mL in 1 BOTTLE, PLASTICLIQUID18932
71819-006-99Dermaharmony Sulfur and Salicylic Acid3785 mL in 1 BOTTLE, PLASTICLIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-006DERMAHARMONY SULFUR AND SALICYLIC ACID (SALICYLIC ACID, SULFUR) LIQUID [D3 DEVELOPMENT, INC.]2Current NDC, Legacy NDC, 5 package rows20241222_a1c61da2-7e7a-430a-e053-2995a90ad594.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71819-00671819-006-04, 71819-006-10, 71819-006-12, 71819-006-64, 71819-006-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLIC ACIDJ94PBK7X8SIACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
PUMICENT5NN5KL16IACT
WATER059QF0KO0RIACT
POTASSIUM COCOATEF8U72V8ZXPIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM OLIVATE3H8EO46QKEIACT
POTASSIUM OLEATE74WHF607EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SULFUR70FD1KFU70ACTIB
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML · Source PDF

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.a1c61da2-7e7a-430a-e053-2995a90ad5942024-12-20WarningsExact identifier
ndc (package): 71819-006-99
ndc (package): 71819-006-04
ndc (package): 71819-006-12
ndc (package): 71819-006-10
ndc (package): 71819-006-64
ndc (product): 71819-006
ndc11 (package): 71819000610
ndc11 (package): 71819000664
ndc11 (package): 71819000612
ndc11 (package): 71819000699
ndc11 (package): 71819000604
spl id: 29ba7e0c-ade1-9f28-e063-6294a90a0037
spl set id: a1c61da2-7e7a-430a-e053-2995a90ad594

Reported adverse events (FAERS/openFDA)#

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