SODIUM SULFACETAMIDE, SULFUR 80 mg/mL
SODIUM SULFACETAMIDE, SULFUR · SUSPENSION · KMM Pharmaceuticals, LLC
Sodium sulfacetamide and sulfur suspension is a topical medication applied to the skin to treat bacterial and fungal skin infections, particularly acne and seborrheic dermatitis. This combination works by reducing bacteria and fungi on the skin surface while helping to clear inflammation and irritation.
Key Facts
- Brand Name
- SODIUM SULFACETAMIDE, SULFUR
- Generic Name
- SODIUM SULFACETAMIDE, SULFUR
- NDC Code (Product)
52187-531- Manufacturer
- KMM Pharmaceuticals, LLC
- Strength
- 80 mg/mL
- Dosage Form
- SUSPENSION
- Route
- TOPICAL
- Marketing Status
- Marketing Start
- 05/20/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 and sulfur suspension is a topical medication applied to the skin to treat bacterial and fungal skin infections, particularly acne and seborrheic dermatitis. This combination works by reducing bacteria and fungi on the skin surface while helping to clear inflammation and irritation.
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 SODIUM SULFACETAMIDE, SULFUR. There are 2 other brand versions of SODIUM SULFACETAMIDE, SULFUR.
What is the NDC code for SODIUM SULFACETAMIDE, SULFUR 80 mg/mL?
The NDC (National Drug Code) for SODIUM SULFACETAMIDE, SULFUR 80 mg/mL is 52187-531, listed by KMM Pharmaceuticals, LLC.