FDA.reportPublic FDA data

MDacne Customized Acne Treatment Cream Sulfur 3.0%

Manufacturer
MDAlgorithms Inc
Effective date
2024-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:22:26

Label at a glance#

ProductMDacne Customized Acne Treatment Sulfur
Active ingredientSULFUR
Label structure8 sections

Dosage and administration

clean the skin thoroughly before applying this product. cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sulfur 3.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Indications:

INDICATIONS & USAGE SECTION

  • For the treatment of acne.
  • Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.

Warnings:

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

broken skin or large areas of the skin. 

When using this product

OTC - WHEN USING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • clean the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.

Other information:

SPL UNCLASSIFIED SECTION

Store in a cool, dry place below 20ºC (70ºF).

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Azelaic Acid, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylyl Glycol, Cetearyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice Extract, Hamamelis Viginiana (Witch Hazel), Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Magnesium Aluminum Silicate, Niacinamide, Olea Europaea (Olive) Oil, Parfum (Fragrance), PEG-150 Distearate, Phenoxyethanol, Polysorbate-80, Potassium Sorbate, Steareth-2, Steareth-20, Tetrasodium EDTA, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Zemea (Com) Propanediol.

Questions:

OTC - QUESTIONS SECTION

Contact us at support@mdacne.com

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label01.jpgOuter Label01.jpgInner Label00.jpgInner Label00.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199632sulfur 3 % Topical CreamPSN1
199632sulfur 30 MG/ML Topical CreamSCD1
199632sulfur 3 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71804-535-00MDacne Customized Acne Treatment Sulfur15 mL in 1 TUBECREAM151
71804-535-00MDacne Customized Acne Treatment Sulfur1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71804-535MDACNE CUSTOMIZED ACNE TREATMENT SULFUR (SULFUR) CREAM [MDALGORITHMS INC]1Current NDC, 2 package rows20241004_236e7d89-006f-07ac-e063-6394a90ab82b.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71804-53571804-535-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
AZELAIC ACIDF2VW3D43YTIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHAMOMILEFGL3685T2XIACT
CUCUMBERYY7C30VXJTIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
WITCH HAZEL101I4J0U34IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
NIACINAMIDE25X51I8RD4IACT
GREEN OLIVE6HD2W46UEGIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
STEARETH-2V56DFE46J5IACT
STEARETH-20L0Q8IK9E08IACT
EDETATE SODIUMMP1J8420LUIACT
THYMECW657OBU4NIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
MDacne Customized Acne Treatment SulfurSULFURMDAlgorithms Inc236e7d89-006f-07ac-e063-6394a90ab82b2024-09-26WarningsExact identifier
ndc (package): 71804-535-00
ndc (product): 71804-535
ndc11 (package): 71804053500
spl id: 236e9a98-1fc1-e6dc-e063-6394a90a684d
spl set id: 236e7d89-006f-07ac-e063-6394a90ab82b

Reported adverse events (FAERS/openFDA)#

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