Drug Facts
Composition & Profile
Identifiers & Packaging
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.; PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label NDC 73352-750-01 Rx Only Sodium Sulfacetamide 10% Sulfur 1% Emulsion FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Net Wt. 177mL Trifluent Pharma, LLC San Antonio TX 78213 Label
- 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.
- PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label NDC 73352-750-01 Rx Only Sodium Sulfacetamide 10% Sulfur 1% Emulsion FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Net Wt. 177mL Trifluent Pharma, LLC San Antonio TX 78213 Label
Overview
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
Indications & Usage
INDICATIONS Sodium Sulfacetamide 10% - Sulfur 1% Emulsion is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & 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.
Warnings & 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
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.
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.
Storage & Handling
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.