Drugplain

Sodium Sulfacetamide, Sulfur 100 mg/g

SULFACETAMIDE SODIUM · CREAM · BioComp Pharma, Inc.

No Recall History
Plain English

Sodium Sulfacetamide, Sulfur is a cream containing sulfacetamide sodium at 100 mg/g, taken topical. Manufactured by BioComp Pharma, Inc..

Key Facts

Brand Name
Sodium Sulfacetamide, Sulfur
Generic Name
SULFACETAMIDE SODIUM
NDC Code (Product)
44523-542
Manufacturer
BioComp Pharma, Inc.
Strength
100 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Marketing Start
09/15/2011

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug hypersensitivity61 reports
drug ineffective39 reports
dyspnoea28 reports
headache27 reports
nausea25 reports
weight decreased23 reports
off label use22 reports
fatigue20 reports
rash20 reports
pain18 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS Sodium Sulfacetamide 9% - Sulfur 4.25% Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage & Administration

DOSAGE AND ADMINISTRATION SHAKE WELL before use. Cleanse affected areas. Apply Sodium Sulfacetamide 9% - Sulfer 4.25% Suspension 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 skin dryness occurs, it may be controlled by rinsing off Sodium Sulfacetamide 9% - Sulfer 4.25% sooner or using less often.

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. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Avoid contact with eyes, lips and mucous membranes. KEEP OUT OF REACH OF CHILDREN. Keep container tightly closed.

Contraindications

CONTRAINDICATIONS Sodium Sulfacetamide 9% - Sulfer 4.25% Supesnion is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9% - Sulder 4.25% Supension is not to be used by patients with kidney disease.

Drug Interactions

Drug Interactions This product is incompatible with silver preparations.

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 ). Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS or obtain product information, contact Allegis Pharmacuticals, LLC at 1-866-633-9033 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Sodium Sulfacetamide, Sulfur used for?

Sodium Sulfacetamide, Sulfur contains SULFACETAMIDE SODIUM. It is a cream taken topical. Consult your doctor for specific uses.

Is Sodium Sulfacetamide, Sulfur a controlled substance?

Sodium Sulfacetamide, Sulfur is not classified as a controlled substance by the DEA.

What is the generic name for Sodium Sulfacetamide, Sulfur?

The generic name for Sodium Sulfacetamide, Sulfur is SULFACETAMIDE SODIUM. There are 11 other brand versions of SULFACETAMIDE SODIUM.

What is the NDC code for Sodium Sulfacetamide, Sulfur 100 mg/g?

The NDC (National Drug Code) for Sodium Sulfacetamide, Sulfur 100 mg/g is 44523-542, listed by BioComp Pharma, Inc..

Product NDC

44523-542

Package NDC

44523-542-02

Other Sodium Sulfacetamide, Sulfur Dosages

Other Sulfacetamide Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)