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SULFACETAMIDE SODIUM / SULFUR EMOLLIENT CREAM 10% / 5% 28.3 GM - 100 mg/g, 50 mg/g CREAM
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SULFACETAMIDE SODIUM / SULFUR EMOLLIENT CREAM 10% / 5% 28.3 GM

Generic: Sodium Sulfacetamide and Sulfur

SULFACETAMIDE SODIUM / SULFUR EMOLLIENT CREAM 10% / 5% 28.3 GM

NDC:42192-0139-01
Manufacturer:Acella Pharmaceuticals, LLC
Strength:100 mg/g, 50 mg/g
Dosage Form:CREAM
Route:TOPICAL

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Drug Information

Identification

Generic Name

Sodium Sulfacetamide and Sulfur

Brand Name

SODIUM SULFACETAMIDE, SULFUR

Labeler / Distributor

Acella Pharmaceuticals, LLC

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

CREAM

Route of Administration

TOPICAL

Active Ingredients

IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR50 mg/g

Pharmacological Class

Sulfonamide AntibacterialSulfonamides [CS]

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Wholesale compliance resources

DSCSA T2 documentsDSCSA compliance resource hub

Drug Resources

Sodium sulfacetamide and sulfur Drug PageNDC 42192-0139-01 Lookup

Clinical Drug Information

Indications & Usage

INDICATIONS: Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Warnings

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. FOR EXTERNAL USE ONLY . Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

Dosage & Administration

DOSAGE AND ADMINISTRATION: 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.

Adverse Reactions

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

Information for Patients

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.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.