Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is available in 16 oz (454 g) bottles, NDC 42192-144-16. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.; PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton NDC 42192-144-16 Sodium Sulfacetamide 9% - Sulfur 4.5% Wash In a vehicle containing Green Tea and Aloe Rx only Net weight 16 oz. Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton
- HOW SUPPLIED: Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is available in 16 oz (454 g) bottles, NDC 42192-144-16. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
- PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton NDC 42192-144-16 Sodium Sulfacetamide 9% - Sulfur 4.5% Wash In a vehicle containing Green Tea and Aloe Rx only Net weight 16 oz. Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton
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 gram of Sodium Sulfacetamide 9% - Sulfur 4% Wash contains 90 mg of Sodium Sulfacetamide and 45 mg of Sulfur in a formulation containing: purified water, sodium cocoyl isethionate, magnesium aluminum silicate, disodium oleamido MEA sulfosuccinate, sodium methyl cocoyl taurate, glyceryl stearate (and) PEG-100 stearate, stearyl alcohol, cetyl alcohol, methyl paraben, propyl paraben, butylated hydroxytoluene, xanthan gum, sodium thiosulfate, green tea extract, aloe vera, disodium EDTA, and fragrance. Chemical Structure
Indications & Usage
INDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
: Apply Sodium Sulfacetamide 9% - Sulfur 4.5% Wash 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 9% - Sulfur 4.5% Wash 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. Keep container tightly closed.
Contraindications
: Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is not to be used by patients with kidney disease.
Adverse Reactions
Although rare, sodium sulfacetamide may cause local irritation.
Storage & Handling
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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