SLMD Silver Sulfur Acne Cream

Manufacturer
Owen Biosciences Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:30

Label at a glance#

ProductSLMD Silver Sulfur Acne Cream
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 applicagtion 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 • Sensitivity T...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

     Sulfur 3.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment 

Use

INDICATIONS & USAGE SECTION

Use for the management of acne

Warnings For external use only.

WARNINGS SECTION

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 topical
acne medication at a time.
•apply only to areas with acne
• avoid contact with the eyes, lips, and mouth

Do not use on:
• broken skin
• large areas of the skin

Stop use and ask a doctor if
irriatation becomes servere.

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

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 applicagtion 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
• Sensitivity Test for a New User:
Apply product sparingly to one or
two small affected areas during
the first 3 days. If no discomfort
occurs, follow the directions
stated above.

INACTIVE INGREDIENT SECTION

Water (aqua), Tromethamine,
C12-15 Alkyl Benzoate, Butylene
Glycol, Prunus Amygdalus Dulcis
(Sweet Almond) Oil, Ethylhexyl
Isononanoate, Glycerin,
Polyglyceryl-3 Methylglucose
Distearate, Cetearyl Alcohol,
Cetyl Dimethicone, Myristyl
Myristate, Cyclopentasiloxane,
Cydotetrasiloxane, Dimethiconol,
Phenoxyethanol, Ethylhexylgly-
gercin, Hydroxyethyl Acrylate/
Sodium Acryloyldimethyl Taurate
Copolymer, Squalane, Polysorbate
60, p-Anisic Acid, Xanthan Gum,
Myristoyl Tetrapeptide-13, Colloidal
Silver Solution

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

Sulfur Carton.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sulfur Carton.jpg

Sulfur Carton.jpgSulfur Carton.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199632sulfur 3 % Topical CreamPSN5
199632sulfur 30 MG/ML Topical CreamSCD5
199632sulfur 3 % Topical CreamSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59958-407-022021-07-15C16284748780-1ba0f9c33-46a4-a910-e053-dadaa90a0b85SLMD Silver Sulfur Acne Cream -407
59958-407-022021-01-29C16284748780-1ba0f9c33-46a4-a910-e053-dadaa90a0b85SLMD Silver Sulfur Acne Cream -407

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-407-01SLMD Silver Sulfur Acne Cream50 g in 1 BOTTLECREAM505
59958-407-02SLMD Silver Sulfur Acne Cream1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-407SLMD SILVER SULFUR ACNE CREAM (SULFUR) CREAM [OWEN BIOSCIENCES INC.]5Current NDC, Legacy NDC, 2 package rows20250114_4735a6d6-bf87-404d-a46d-7f29fcff9409.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59958-40759958-407-01, 59958-407-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALMOND OIL66YXD4DKO9IACT
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
SLMD Silver Sulfur Acne CreamSULFUROwen Biosciences Inc.4735a6d6-bf87-404d-a46d-7f29fcff94092025-01-13WarningsExact identifier
ndc (package): 59958-407-02
ndc (package): 59958-407-01
ndc (product): 59958-407
ndc11 (package): 59958040701
ndc11 (package): 59958040702
spl id: 2b99c446-32db-c45d-e063-6394a90a318f
spl set id: 4735a6d6-bf87-404d-a46d-7f29fcff9409

Reported adverse events (FAERS/openFDA)#

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