Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is available in 10 fl oz (296 mL) bottles NDC 83720-542-10.; Manufactured In USA For : Oncor Pharmaceuticals 6755 Business Pkwy Suite 202 Elkridge, MD 21075 United States. Rev. 08/25 sss 8-4 topical suspension 10 oz sss 8-4 topical suspension 16 oz
- HOW SUPPLIED Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is available in 10 fl oz (296 mL) bottles NDC 83720-542-10.
- Manufactured In USA For : Oncor Pharmaceuticals 6755 Business Pkwy Suite 202 Elkridge, MD 21075 United States. Rev. 08/25 sss 8-4 topical suspension 10 oz sss 8-4 topical suspension 16 oz
Overview
Each gram of Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension contains 80 mg of sodium sulfacetamide and 40 mg of sulfur in a formulation containing 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, Xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemica ly sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: structure
Indications & Usage
INDICATIONS Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
Apply Sodium Sulfacetamide 8% and Sulfur 4% Topical 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 drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension 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.
Contraindications
This product is contraindicated for use by persons with known or suspected hypersensitivity to sulfonamides, sulfur or any other component of this preparation. This product is not to be used by patients with kidney disease.
Adverse Reactions
Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.
Storage & Handling
STORAGE Store at 20 o C to 25 o C ( 68 o F to 77 o F ), excursions permitted between 15 o C and 30 o C (between 59 o F and 86 o F ). Brief exposure to temperatures up to 40°C (104 o F) may be tolerated provided the mean kinetic temperature does not exceed 25 o C (77 o F) however, such exposure should be minimized. Protect from freezing.
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