Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sodium Sulfacetamide 9% - Sulfur 4.25% Suspension is available in 8 fl oz (237 mL) bottles, NDC 28595-501-08. 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 - 237 mL Bottle Label NDC 28595-501-08 Rx Only Sodium Sulfacetamide 9% Sulfur 4.25% Suspension Topical Suspension in a vehicle containing Green Tea and Aloe FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE SHAKE WELL Net Wt. (8oz) 237mL Allegis Pharmaceuticals, LLC Canton MS 39046 Label
- HOW SUPPLIED Sodium Sulfacetamide 9% - Sulfur 4.25% Suspension is available in 8 fl oz (237 mL) bottles, NDC 28595-501-08. 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 - 237 mL Bottle Label NDC 28595-501-08 Rx Only Sodium Sulfacetamide 9% Sulfur 4.25% Suspension Topical Suspension in a vehicle containing Green Tea and Aloe FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE SHAKE WELL Net Wt. (8oz) 237mL Allegis Pharmaceuticals, LLC Canton MS 39046 Label
Overview
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: Each mL contains 90 mg of sodium sulfacetamide and 42.5 mg of sulfur in vehicle consisting of aloe vera leaf extract, butylated hydroxytoluene, cetyl alcohol, citric acid, cocamidopropyl betaine, disodium EDTA, glycerin, glyceryl stearate SE, green tea extract, PEG 100 stearate, phenoxyethanol, purified water, sodium laureth sulfate, sodium thiosulfate, stearyl alcohol, triacetin and xanthan gum. Chemical Structure
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
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 & 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. 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
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.
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.
Drug Interactions
This product is incompatible with silver preparations.
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.
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