Sodium Sulfacetamide 10% - Sulfur 5%
- Manufacturer
- Acella Pharmaceuticals, LLC
- Effective date
- 2026-07-23
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 9
- Source
- daily-update
- Hydrated at
- 2026-10-14 00:02:27
Label at a glance#
ProductSodium Sulfacetamide 10 Sulfur 5 Cleanser
Active ingredientSULFACETAMIDE SODIUM, SULFUR
Label structure15 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Rx Only
DESCRIPTION SECTION
DESCRIPTION:Each ml of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in a formulation containing Butylated Hydroxytoluene, Cetyl Alcohol, Disodium EDTA, Disodium Oleamido MIPA Sulfosuccinate, Glyceryl Slearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Cocoyl lsethionate, Sodium Melhyl Cocoyl Taurale, Sodium Thiosulfate, Stearyl Alcohol, Xanthan Gum.
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl)-acetamide, monosodium salt, monohydrate.
The structural formula is:
CLINICAL PHARMACOLOGY SECTION
CLINICAL PHARMACOLOGY:The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
INDICATIONS & USAGE SECTION
INDICATIONS:Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS SECTION
CONTRAINDICATIONS:Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is not to be used by patients with kidney disease.
WARNINGS SECTION
WARNINGS:Although rare, sensitivity to sodium sulfacetaminde may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.
SPL UNCLASSIFIED SECTION
FOR EXTERNAL USE ONLY.Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
PRECAUTIONS:
GENERAL PRECAUTIONS SECTION
General -If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.
INFORMATION FOR PATIENTS SECTION
Information for patients -Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
Carcinogenesis, Mutagenesis and Impairment of Fertility -Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PREGNANCY SECTION
PREGNANCY:Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% - Sulfur 5% Cleanser. It is not known whether Sodium Sulfacetamide 10% - Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 5% Cleanser should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS SECTION
NURSING MOTHERS:It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is administered to a nursing woman.
PEDIATRIC USE SECTION
PEDIATRIC USE:Safety and effectiveness in children under the age of 12 have not been established.
ADVERSE REACTIONS SECTION
ADVERSE REACTIONS:Although rare, sodium sulfacetamide may cause local irritation.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION:Apply Sodium Sulfacetamide 10% - Sulfur 5% Cleanser once or twice daily to affected areas, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 10% - Sulfur 5% Cleanser sooner or using less often.
SPL UNCLASSIFIED SECTION
MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30005 • 1-800-541-4802
L-0091 Rev. 1123-02
HOW SUPPLIED SECTION
HOW SUPPLIED:Sodium Sulfacetamide 10% - Sulfur 5% Topical Suspension is available in 6 oz (170.3 g) bottles, NDC 42192-136-06, 8 oz (227 g) bottles, 42192-136-08 and 12 oz (340.2 g) bottles, NDC 42192-136-12.
STORAGE AND HANDLING SECTION
Store at 20° -25°C (68°-77°F); excursions permitted to 15° - 30°C (59° -86°F). [See USP Controlled Room Temperature). Protect from freezing.
SPL UNCLASSIFIED SECTION
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
All prescription substitutions using this product shall be made subject to state and federal statutes as applicable.
SPL UNCLASSIFIED SECTION
NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency.Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.
PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label
NDC 42192-136-06
Sodium Sulfacetamide 10% -
Sulfur 5%
Cleanser
Rx Only
SHAKE WELL BEFORE USE
6 oz (170.3 g)
Acella
PHARMACEUTICALS, LLC
NDC 42192-136-08
Sodium Sulfacetamide 10% -
Sulfur 5% Cleanser
Rx Only
SHAKE WELL BEFORE USE
8 oz (227 g)
Acella
PHARMACEUTICALS, LLC
NDC 42192-136-12
Sodium Sulfacetamide 10% -
Sulfur 5% Cleanser
Rx Only
SHAKE WELL BEFORE USE
12 oz (340.2 g)
Acella
PHARMACEUTICALS, LLC
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4073022c-5d5d-48f5-82ed-091ad146a4b2 | Product name | 1 | 20171211 |
| 9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5 | Product name | 1 | 20150828 |
| 0304b7d2-7a07-d53b-750f-36012ae6612e | Product name | 1 | 20140508 |
| 64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6 | Product name | 1 | 20140508 |
| 9ae74339-0a3d-82e9-5dd1-88bd2607bd6b | Product name | 1 | 20140508 |
| e44e38a9-2d9e-b0e2-cce9-490554639f3d | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42192-136-06 | GM - Gram | 42192-136 | cdd8ae71-f151-445f-a2ec-d55d66c4299c | 1 | 2013-02-13 |
| 42192-136-08 | GM - Gram | 42192-136 | e44f6fad-b0e4-4a33-9cdf-7a55a92a7b45 | 1 | 2016-09-02 |
| 42192-136-12 | GM - Gram | 42192-136 | 7a3a14af-b2ee-4dff-848c-41e0cfacc6ab | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Sulfacetamide Sodium | ACTIVE INGREDIENT | 4NRT660KJQ | 1 | |
| Sulfur | ACTIVE INGREDIENT | 70FD1KFU70 | 1 | |
| Sulfacetamide | ACTIVE MOIETY | 4965G3J0F5 | 1 | |
| Sulfur | ACTIVE MOIETY | 70FD1KFU70 | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SODIUM COCOYL ISETHIONATE | INACTIVE INGREDIENT | 518XTE8493 | 1 | |
| SODIUM METHYL COCOYL TAURATE | INACTIVE INGREDIENT | JVL98CG53G | 1 | |
| SODIUM THIOSULFATE | INACTIVE INGREDIENT | HX1032V43M | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Sodium Sulfacetamide 10 Sulfur 5 Cleanser
- Sulfacetamide Sodium and Sulfur
- SULFACETAMIDE SODIUM
- SULFACETAMIDE
- SULFUR
- BUTYLATED HYDROXYTOLUENE
- CETYL ALCOHOL
- EDETATE DISODIUM
- GLYCERYL MONOSTEARATE
- PEG-100 STEARATE
- MAGNESIUM ALUMINUM SILICATE
- METHYLPARABEN
- PROPYLPARABEN
- WATER
- SODIUM COCOYL ISETHIONATE
- SODIUM METHYL COCOYL TAURATE
- SODIUM THIOSULFATE
- STEARYL ALCOHOL
- PETROLATUM
- XANTHAN GUM
- DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42192-136 | 42192-136-06, 42192-136-08, 42192-136-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 8 | 2026-07-14 | daily-update | 2026-07-18 05:10:29 |
| 6 | 2024-01-11 | full-release | 2026-05-31 20:57:55 |
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO / TOPICAL | 1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / TOPICAL | 3.27 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| SODIUM THIOSULFATE | SODIUM THIOSULFATE | HX1032V43M | CREAM / TOPICAL | 6 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LOTION / TOPICAL | 1.5 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| PEG-100 STEARATE | PEG-100 MONOSTEARATE | YD01N1999R | LOTION / TOPICAL | 1 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | LOTION / TOPICAL | 1000 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY / TOPICAL | 3 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SWAB / TOPICAL | 0.5 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | OINTMENT / TOPICAL | 57 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / TOPICAL | 216 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| SODIUM COCOYL ISETHIONATE | SODIUM COCOYL ISETHIONATE | 518XTE8493 | SHAMPOO / TOPICAL | 1 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| PEG-100 STEARATE | PEG-100 MONOSTEARATE | YD01N1999R | LOTION / TOPICAL | 1 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | OINTMENT / TOPICAL | 57 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / TOPICAL | 126 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION / TOPICAL | 3 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | AEROSOL, FOAM / TOPICAL | 37 mg | ||
| SODIUM METHYL COCOYL TAURATE | SODIUM METHYL COCOYL TAURATE | JVL98CG53G | SHAMPOO / TOPICAL | 65 %w/w | ||
| SODIUM THIOSULFATE | SODIUM THIOSULFATE | HX1032V43M | CREAM / TOPICAL | 6 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / TOPICAL | 126 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOTION / TOPICAL | 0.3 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY / TOPICAL | 3 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY / TOPICAL | 3 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / TOPICAL | 180 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SWAB / TOPICAL | 0.5 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL, METERED / TOPICAL | 4 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LOTION / TOPICAL | 1.5 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | AEROSOL, FOAM / TOPICAL | 0.04 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / TOPICAL | 0.24 %w/v | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | EMULSION / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | OINTMENT / TOPICAL | 1 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL / TOPICAL | 8 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sodium Sulfacetamide 10 Sulfur 5 Cleanser | SULFACETAMIDE SODIUM AND SULFUR | Acella Pharmaceuticals, LLC | 1926eadd-d11f-44fa-971f-0041060f7589 | 2026-07-14 | Warnings, Adverse reactions | 42192-136-12 42192-136-08 42192-136-06 42192-136 42192013612 42192013608 42192013606 1926eadd-d11f-44fa-971f-0041060f7589 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.