Sodium Sulfacetamide, Sulfur
FDA Drug Information • Also known as: Sodium Sulfacetamide - Sulfur Wash, Sodium Sulfacetamide And Sulfur, Sodium Sulfacetamide, Sulfur
- Brand Names
- Sodium Sulfacetamide - Sulfur Wash, Sodium Sulfacetamide And Sulfur, Sodium Sulfacetamide, Sulfur
- Drug Class
- Sulfonamide Antibacterial [EPC]
- Route
- TOPICAL
- Dosage Form
- LIQUID
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION: Each mL contains 80 mg of sodium sulfacetamide and 40 mg of colloidal sulfur in a vehicle consisting of: aloe vera gel, benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S·H 2 O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether. structure.jpg
What Is Sodium Sulfacetamide, Sulfur Used For?
INDICATIONS: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage and Administration
DOSAGE AND ADMINISTRATION: Apply this product 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 drying occurs, it may be controlled by rinsing off sooner or using less often.
Side Effects (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 ).
Warnings and Precautions
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.
Overdosage
OVERDOSAGE: The oral LD 50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately. Manifestations: Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center or your doctor.
How Supplied
HOW SUPPLIED: 16 fl. oz.(473 mL) bottles, NDC 24470-951-16 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Cintex Services, LLC Dallas, TX 75243 2500237 [00] Rev. 08/2025
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.