Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is available in 16 fl oz (473 mL) bottles, NDC 42192-133-16.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42192-133-16 Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension In a vehicle containing Green Tea and Aloe Rx Only SHAKE WELL 16 fl. oz. (473 mL) Acella PHARMACEUTICALS, LLC Container
- HOW SUPPLIED: Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is available in 16 fl oz (473 mL) bottles, NDC 42192-133-16.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42192-133-16 Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension In a vehicle containing Green Tea and Aloe Rx Only SHAKE WELL 16 fl. oz. (473 mL) Acella PHARMACEUTICALS, LLC Container
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 of Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension contains 80 mg of Sodium Sulfacetamide and 40 mg of Sulfur in a formulation containing purified water, sodium cocoyl isethionate, disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100 stearate, methyl paraben, propyl paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosulfate, disodium EDTA, magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl taurate and white petrolatum. Structural Formula
Indications & Usage
INDICATIONS: Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
: Apply Sodium Sulfacetamide 8% - 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% - Sulfur 4% Topical Suspension sooner or using less often.
Warnings & Precautions
WARNINGS: Although rare, sensitivity to sodium sulfacetaminde 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 8% - Sulfur 4% Topical Suspension is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 8% - Sulfur 4% Topical Suspension is not to be used by patients with kidney disease.
Adverse Reactions
Although rare, sodium sulfacetamide may cause local irritation.
Storage & Handling
Store at controlled room temperature, 15° - 30°C (59° - 86°F). Protect from freezing.
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