FDA.reportPublic FDA data

MDacne Customized Cream (Sulfur)

Manufacturer
MDalgorithms Inc.
Effective date
2022-02-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:09

Label at a glance#

ProductMDacne Customized Cream (Sulfur)
Active ingredientSULFUR
Label structure10 sections

Label contents#

Full prescribing information#

DRUG FACTS:

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:

Sulfur 3.0%

OTC - PURPOSE SECTION

Acne Treatment

INDICATIONS & USAGE SECTION

Indications: ■ 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 SECTION

Warnings For external use only
Do not useon broken skin or large areas of
the skin. When using this product ■ 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 acne medication at one time. ■ apply
only to areas with acne.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed,
get medical help or contact a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask

a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions: ■ 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 directed by a doctor. ■ if
bothersome dryness or peeling occurs reduce
application to once a day or every other day.

INACTIVE INGREDIENT SECTION

Other Ingredients: 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) Extract, Dimethicone, Glycerin,
Glycyrrhiza Glabra (Licorice) Extract,
Hamamelis Virginiana (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,
Tocopherol (Vitamin E), Zemea (Corn)
Propanediol.

OTC - QUESTIONS SECTION

Questions?  Dist. by Mdalgorithms Inc. San

Francisco, CA 94104.  Manufactured in the

USA.  For customer support contact us at

support@mdacne.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MDacne

Customized 

Treatment

Cream

Night

Dermatologist Tested

Sulfur 3.0%

0.5 Oz | 15 mL

SulfurSulfur

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199632sulfur 3 % Topical CreamPSN2
199632sulfur 30 MG/ML Topical CreamSCD2
199632sulfur 3 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71804-400-012024-01-30C16284748780-1d6a99b39-fcd8-a426-e053-dadaa90af4c2b3ea8695-1127-49fd-901f-167a00a886a1
71804-400-012022-02-09C16284748780-1d6a99b39-fcd8-a426-e053-dadaa90af4c2b3ea8695-1127-49fd-901f-167a00a886a1
71804-400-012022-01-28C16284748780-1d6a99b39-fcd8-a426-e053-dadaa90af4c2b3ea8695-1127-49fd-901f-167a00a886a1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71804-400-01MDacne Customized Cream (Sulfur)15 mL in 1 TUBECREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71804-400MDACNE CUSTOMIZED CREAM (SULFUR) (SULFUR 3%) CREAM [MDALGORITHMS INC.]2Legacy NDC, 1 package rows20220210_b3ea8695-1127-49fd-901f-167a00a886a1.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71804-40071804-400-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
AZELAIC ACIDF2VW3D43YTIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHAMOMILEFGL3685T2XIACT
CUCUMBERYY7C30VXJTIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
WITCH HAZEL101I4J0U34IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
NIACINAMIDE25X51I8RD4IACT
OLIVE OIL6UYK2W1W1EIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
STEARETH-2V56DFE46J5IACT
STEARETH-20L0Q8IK9E08IACT
EDETATE SODIUMMP1J8420LUIACT
THYMECW657OBU4NIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CORN0N8672707OIACT

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
80392baf-fd94-4d70-b3f1-cc9a0e0eeeb5b3ea8695-1127-49fd-901f-167a00a886a12022-02-09WarningsExact identifier
spl id: 80392baf-fd94-4d70-b3f1-cc9a0e0eeeb5
spl set id: b3ea8695-1127-49fd-901f-167a00a886a1

Reported adverse events (FAERS/openFDA)#

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