Sodium Sulfacetamide And Sulfer
FDA Drug Information • Also known as: Sodium Sulfacetamide And Sulfer Emulsion
- Brand Names
- Sodium Sulfacetamide And Sulfer Emulsion
- Route
- TOPICAL
- Dosage Form
- EMULSION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Each gram of Sodium Sulfacetamide 10% and Sulfur 1% Emulsion contains 100 mg of sodium sulfacetamide and 10 mg of sulfur in a formulation containing Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Chemical Structure
What Is Sodium Sulfacetamide And Sulfer Used For?
INDICATIONS Sodium Sulfacetamide 10% - Sulfur 1% Emulsion is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply Sodium Sulfacetamide 10% and Sulfur 1% Emulsion 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 Sodium Sulfacetamide 10% and Sulfur 1% Emulsion sooner or using less often.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects. To report a serious adverse event, please contact Trifluent Pharma, LLC at 1-888-927-5191.
Warnings and Precautions
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. FOR EXTERNAL USE ONLY . Keep away from eyes. Keep out of reach of children. In case of accidental ingestion contact a poison control center immediately. Keep container tightly closed.
Contraindications
CONTRAINDICATIONS Sodium Sulfacetamide 10% and Sulfur 1% Emulsion is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% and Sulfer 1% Emulsion is not to be used by patietns with kidney disease.
Pregnancy and Breastfeeding
PREGNANCY - Category C Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfer 1% Emulsion. It is not known whether Sodium Sulfacetamide 10% and Sulfer 1% Emulsion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Silfacetamide 10% and Sulfer 1% Emulsion should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% and Sulfur 1% Emulsion. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% and Sulfur 1% Emulsion is administered to a nursing woman.
How Supplied
HOW SUPPLIED Sodium Sulfacetamide 10% and Sulfur 1% Emulsion is available in 177 mL bottles, NDC 73352-750-01. STORAGE AND HANDLING Store at controlled room temperature, 15° - 30°C (59° - 86°F). Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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.