Sulfacetamide Sodium, Sulfur
FDA Drug Information • Also known as: Avar, Avar Ls, Avar-E, Avar-E Green, Avar-E Ls, Plexion, Sodium Sulfacetamide 10% And Sulfur 2%...
- Brand Names
- Avar, Avar Ls, Avar-E, Avar-E Green, Avar-E Ls, Plexion, Sodium Sulfacetamide 10% And Sulfur 2% Cleanser, Sodium Sulfacetamide 10% And Sulfur 5% Cleanser, Sodium Sulfacetamide 8% And Sulfur 4%, Sodium Sulfacetamide 8% And Sulfur 4% Cleanser, Sodium Sulfacetamide 9% - Sulfur 4%, Sodium Sulfacetamide 9% - Sulfur 4.5% Wash, Sodium Sulfacetamide 9% And Sulfur 4% Cleanser, Sodium Sulfacetamide 9% And Sulfur 4.5% Cleanser, Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser, Sodium Sulfacetamide And Sulfur, Sodium Sulfacetamide, Sulfur, Sulfacetamide Sodium, Sulfur
- Route
- TOPICAL
- Dosage Form
- CREAM
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION: Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, glyceryl stearate (and) PEG-100 stearate, 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
What Is Sulfacetamide Sodium, 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: Shake well before use. 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.
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 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: 30 g bottles, NDC 24470-934-01 60 g bottles, NDC 24470-934-02 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Cintex Services, LLC 9330 LBJ Freeway, Suite 900 Dallas, TX 75243 2300382 [00] Rev. 12/2023
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.