Drugplain

SULFACETAMIDE SODIUM, SULFUR 98 mg/g

SULFACETAMIDE SODIUM, SULFUR · LOTION · KMM Pharmaceuticals, LLC

No Recall History
Plain English

Sulfacetamide sodium and sulfur lotion is a prescription medication applied directly to the skin to treat acne and other bacterial skin infections. This combination works by reducing bacteria and excess oil on the skin's surface.

Key Facts

Brand Name
SULFACETAMIDE SODIUM, SULFUR
Generic Name
SULFACETAMIDE SODIUM, SULFUR
NDC Code (Product)
52187-548
Manufacturer
KMM Pharmaceuticals, LLC
Strength
98 mg/g
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Marketing Start
03/31/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

anti-neutrophil cytoplasmic antibody positive vasculitis2 reports
brain stem ischaemia2 reports
iiird nerve paralysis2 reports
abdominal pain upper1 reports
alopecia1 reports
chronic kidney disease1 reports
diarrhoea1 reports
diplopia1 reports
incorrect drug administration duration1 reports
incorrect product dosage form administered1 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: Wash affected areas once or twice daily, or as directed by your physician. 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 skin dryness occurs, it may be controlled by rinsing product off sooner or using less frequently.

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 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 SULFACETAMIDE SODIUM, SULFUR used for?

Sulfacetamide sodium and sulfur lotion is a prescription medication applied directly to the skin to treat acne and other bacterial skin infections. This combination works by reducing bacteria and excess oil on the skin's surface.

Is SULFACETAMIDE SODIUM, SULFUR a controlled substance?

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

What is the generic name for SULFACETAMIDE SODIUM, SULFUR?

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

What is the NDC code for SULFACETAMIDE SODIUM, SULFUR 98 mg/g?

The NDC (National Drug Code) for SULFACETAMIDE SODIUM, SULFUR 98 mg/g is 52187-548, listed by KMM Pharmaceuticals, LLC.

Product NDC

52187-548

Package NDC

52187-548-02

Other SULFACETAMIDE SODIUM, 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)