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SODIUM SULFACETAMIDE WASH 0.1 480ML - 100 mg/mL LIQUID
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SODIUM SULFACETAMIDE WASH 0.1 480ML

Generic: SODIUM SULFACETAMIDE

SODIUM SULFACETAMIDE WASH 0.1 480ML

NDC:42192-0129-16
Manufacturer:Acella Pharmaceuticals, LLC
Strength:100 mg/mL
Dosage Form:LIQUID
Route:TOPICAL

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Drug Information

Identification

Generic Name

SODIUM SULFACETAMIDE

Brand Name

SODIUM SULFACETAMIDE

Labeler / Distributor

Acella Pharmaceuticals, LLC

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

LIQUID

Route of Administration

TOPICAL

Active Ingredients

IngredientStrength
SULFACETAMIDE SODIUM100 mg/mL

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% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Warnings

WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitivie 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 THE REACH OF CHILDREN.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Seborrheic dermatitis including seborrhea sicca - Wash affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. Regular shampooing following Sodium Sulfacetamide 10% Wash is not necessary, but the hair should be shampooed at least once a week. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of Sodium Sulfacetamide 10% Wash should be reinstated as at the beginning of treatment. Secondary Cutaneuos Bacterial Infections - Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. if skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.

Adverse Reactions

ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported. (See warnings .)

Information for Patients

Information for patients - Patients should discontinue use of Sodium Sulfacetamide 10% Wash if the condition worsens, or is a rash develops in the area being treated or elsewhere. Sodium Sulfacetamide 10% Wash also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop.

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