Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily or as directed by a physician. To minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician.
Rx Only
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:
Each gram of Sodium Sulfacetamide 10% Sulfur 2% Cream contains 100 mg of Sodium Sulfacetamide and 20 mg of Sulfur in a base containing BHT, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol,Disodium EDTA, Ethylhexyl Palmitate, Ethylparaben, Fragrance, Glyceryl Monostearate SE, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Sodium Thiosulfate and Xanthan Gum.
Sodium Sulfacetamide exhibits antibacterial activity. It is believed to block bacterial growth by acting as a competitive antagonist of para-aminobenzoic acid (PABA). While absorption through intact skin has not been determined for sodium sulfacetamide, it is estimated that 1% of topically applied sulfur is absorbed. Although the exact mode of the keralytic activity of sulfur is unknown, it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfur has been reported to inhibit P. acnes, thereby reducing the associated inflammation.
Sodium Sulfacetamide 10% Sulfur 2% Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Sodium Sulfacetamide 10% Sulfur 2% Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% Sulfur 2% Cream is not to be used by patients with kidney disease.
Although rare, sensitivity to sodium sulfacetamide 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.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
PRECAUTIONS: 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 -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 and Impairment of Fertility- Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy: Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% Sulfur 2% Cream. It is not known whether Sodium Sulfacetamide 10% Sulfur 2% Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% Sulfur 2% Cream should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% Sulfur 2% Cream. 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 2% Cream is administered to a nursing woman.
PEDIATRIC USE: Safety and effectiveness in children under the age of 12 have not been established.
Although rare, sodium sulfacetamide may cause local irritation.
Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily or as directed by a physician. To minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician.
Sodium Sulfacetamide 10% Sulfur 2% Cream is available in 2 oz (57 g) bottles, NDC 42192-150-02.
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]
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. 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.
MANUFACTURED FOR:Acella Pharmaceuticals, LLC
Alpharetta, GA 30022 • 1-800-541-4802
L-0121 Rev. 0121-01
NDC 42192-150-02
Rx Only
Sulfacetamide Sodium 10%
Sulfur 2% Cream
Net wt. 2 oz (57 g)
Acella
PHARMACEUTICALS, LLC
| 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 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42192-150-02 | GM - Gram | 42192-150 | 26c346ae-d636-46cf-af2c-f52467e11872 | 1 | 2014-09-03 |
| 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 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 1 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYOXYL 20 CETOSTEARYL ETHER | INACTIVE INGREDIENT | YRC528SWUY | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SODIUM THIOSULFATE | INACTIVE INGREDIENT | HX1032V43M | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42192-150 | 42192-150-02 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-03-06 | full-release | 2026-05-31 21:33:16 |
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 |
|---|---|---|---|---|---|---|
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | GRANULE, FOR SOLUTION / ORAL | 14 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| SODIUM THIOSULFATE | SODIUM THIOSULFATE | HX1032V43M | CREAM / TOPICAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SUSPENSION / ORAL | 8 mg | ||
| POLYOXYL 20 CETOSTEARYL ETHER | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | CREAM / TOPICAL | 180 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| SODIUM THIOSULFATE | SODIUM THIOSULFATE | HX1032V43M | CREAM / TOPICAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SOLUTION / ORAL | 14 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SUSPENSION / ORAL | 8 mg | ||
| POLYOXYL 20 CETOSTEARYL ETHER | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | CREAM / TOPICAL | 180 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | GRANULE, FOR SOLUTION / ORAL | 14 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SOLUTION / ORAL | 14 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg |
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 2 cream | SULFACETAMIDE SODIUM AND SULFUR | Acella Pharmaceuticals, LLC | a57b734d-5d6d-4cd7-8003-9174cc785e41 | 2026-07-13 | Warnings, Adverse reactions | 42192-150-02 42192-150 42192015002 5681cd4e-9ca2-18b5-e063-6294a90af0ae a57b734d-5d6d-4cd7-8003-9174cc785e41 |
Adverse event summaries are temporarily unavailable. Other product information remains available.