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SULFACETAMIDE SODIUM / SULFUR CLEANSER 10% / 2% 227 GM - 100 mg/g, 20 mg/g SOLUTION
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SULFACETAMIDE SODIUM / SULFUR CLEANSER 10% / 2% 227 GM

Generic: Sulfacetamide Sodium and Sulfur

SULFACETAMIDE SODIUM / SULFUR CLEANSER 10% / 2% 227 GM

NDC:42192-0147-08
Manufacturer:Acella Pharmaceuticals, LLC
Strength:100 mg/g, 20 mg/g
Dosage Form:SOLUTION
Route:TOPICAL

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Drug Information

Identification

Generic Name

Sulfacetamide Sodium and Sulfur

Brand Name

Sodium Sulfacetamide 10 Sulfur 2 Cleanser

Labeler / Distributor

Acella Pharmaceuticals, LLC

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

SOLUTION

Route of Administration

TOPICAL

Active Ingredients

IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR20 mg/g

Pharmacological Class

Sulfonamide AntibacterialSulfonamides [CS]

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

Clinical Drug Information

Indications & Usage

INDICATIONS: SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Warnings

WARNINGS: 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. Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF REACH OF CHILDREN.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Wash affected areas with SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER 1 to 2 times daily or as directed by a physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10 to 20 seconds working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using cleanser less often.

Adverse Reactions

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.

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