FDA.reportPublic FDA data

Dermaharmony 10% Sulfur

Manufacturer
D3 Development, Inc. | Vanguard Soap, LLC.
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:19:09

Label at a glance#

ProductDermaharmony 10% Sulfur with Tea Tree Oil
Active ingredientSULFUR
Label structure11 sections

Storage and handling

Other information Store at room temperature in a dry place.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sulfur 10%

OTC - PURPOSE SECTION

Purpose

Acne medication soap

INDICATIONS & USAGE SECTION

Uses

  • For the treatment of acne.
  • Clears acne blemishes, blackheads, and whiteheads.

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on

  • broken skin.
  • large areas of the skin.

OTC - WHEN USING SECTION

When using this product

  • apply only to areas with acne.
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

OTC - STOP USE SECTION

Stop use and ask a doctor ifskin irritation occurs or gets worse.

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

  • using warm water, wash affected area for 1-2 minutes, avoiding contact with the eyes.
  • rinse thoroughly and pat dry with a clean towel.
  • because excessive drying of the skin may occur start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor.
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

STORAGE AND HANDLING SECTION

Other informationStore at room temperature in a dry place.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, tea tree (Melaleuca alternifolia) oil, sodium chloride, coconut (Cocos nucifera) fruit extract, palm (Elaeis guineensis) fruit extract, pentasodium penetate

*May contain this ingredient

SPL UNCLASSIFIED SECTION

Distributed by: D3 Development, Inc., Portland, ME 04101

Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

10% Sulfur SOAP with Tea Tree Oil

For Acne Pimples, Blackheads & Whiteheads

NET WT 4 OZ (113 G)

Image of labelImage of labelimage of cartonimage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313147sulfur 10 % Medicated Bar SoapPSN3
313147sulfur 0.1 MG/MG Medicated Bar SoapSCD3
313147sulfur 10 % Medicated Bar SoapSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860004825845GTIN-13: 0860004825845
EAN-13: 0860004825845
GTIN-12: 860004825845
UPC-A: 860004825845
GTIN storage (14 digits): 00860004825845		Sulfur Acne Soap TTO Carton.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-015-04Dermaharmony 10% Sulfurwith Tea Tree Oil113 g in 1 POUCHSOAP1133
71819-015-05Dermaharmony 10% Sulfurwith Tea Tree Oil113 g in 1 CARTONSOAP1133

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
71819-01571819-015-04, 71819-015-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GIACT
ELAEIS GUINEENSIS FRUIT80T6U6714JIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PALMATES0A6004K3ZIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
SODIUM COCOATER1TQH25F4IIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PENTASODIUM PENTETATE961TOZ5L7TIACT
COCONUT3RT3536DHYIACT
SULFUR70FD1KFU70ACTIB

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 10% Sulfur with Tea Tree OilSULFURD3 Development, Inc.c79005d4-0c6f-75d0-e053-2995a90a83142025-12-01WarningsExact identifier
ndc (package): 71819-015-04
ndc (package): 71819-015-05
ndc (product): 71819-015
ndc11 (package): 71819001505
ndc11 (package): 71819001504
spl id: 44e80bdf-28fd-1659-e063-6394a90a2278
spl set id: c79005d4-0c6f-75d0-e053-2995a90a8314

Reported adverse events (FAERS/openFDA)#

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