SODIUM SULFACETAMIDE AND SULFUR 90 mg/g

sodium sulfacetamide, sulfur · LOTION · BioComp Pharma, Inc.

No Recall HistoryCurrently in Shortage

Plain English

SODIUM SULFACETAMIDE AND SULFUR is a lotion containing sodium sulfacetamide, sulfur at 90 mg/g, taken topical. Manufactured by BioComp Pharma, Inc..

Key Facts

Brand Name: SODIUM SULFACETAMIDE AND SULFUR
Generic Name: sodium sulfacetamide, sulfur
NDC Code (Product): 44523-605
Manufacturer: BioComp Pharma, Inc.
Strength: 90 mg/g
Dosage Form: LOTION
Route: TOPICAL
Marketing Status
Marketing Start: 04/15/2011

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective4 reports

erythema3 reports

hypersensitivity3 reports

impaired quality of life3 reports

sleep disorder3 reports

anti-neutrophil cytoplasmic antibody positive vasculitis2 reports

asthma2 reports

brain stem ischaemia2 reports

diarrhoea2 reports

dry skin2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician.

Warnings

WARNINGS: 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 THE REACH OF CHILDREN.

Contraindications

CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

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).

Frequently Asked Questions

What is SODIUM SULFACETAMIDE AND SULFUR used for?

SODIUM SULFACETAMIDE AND SULFUR contains sodium sulfacetamide, sulfur. It is a lotion taken topical. Consult your doctor for specific uses.

Is SODIUM SULFACETAMIDE AND SULFUR a controlled substance?

SODIUM SULFACETAMIDE AND SULFUR is not classified as a controlled substance by the DEA.

What is the generic name for SODIUM SULFACETAMIDE AND SULFUR?

The generic name for SODIUM SULFACETAMIDE AND SULFUR is sodium sulfacetamide, sulfur. There are 7 other brand versions of sodium sulfacetamide, sulfur.

What is the NDC code for SODIUM SULFACETAMIDE AND SULFUR 90 mg/g?

The NDC (National Drug Code) for SODIUM SULFACETAMIDE AND SULFUR 90 mg/g is 44523-605, listed by BioComp Pharma, Inc..

Product NDC

44523-605

Package NDC

44523-605-16

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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)