Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Sulfacetamide Sodium 10% and Sulfur 2% cleanser is supplied in 8 oz (227 g) bottle NDC #50405-851-01 Store at 20°-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F). Brief exposure to temperatures up to 40° (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. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN; PRINCIPAL DISPLAY PANEL - 227 g Bottle Label NDC 50405-851-01 Sodium Sulfacetamide 10% and Sulfur 2% Cleanser Rx Only 8 oz (227 g) label-227g
- HOW SUPPLIED: Sulfacetamide Sodium 10% and Sulfur 2% cleanser is supplied in 8 oz (227 g) bottle NDC #50405-851-01 Store at 20°-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F). Brief exposure to temperatures up to 40° (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. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL - 227 g Bottle Label NDC 50405-851-01 Sodium Sulfacetamide 10% and Sulfur 2% Cleanser Rx Only 8 oz (227 g) label-227g
Overview
Sulfacetamide Sodium is a sulfonamide with antibacterial activity while Sulfur acts as a keratolytic agent. Chemically Sulfacetamide Sodium is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Each gram of Sodium Sulfacetamide 10% and Sulfur 2% Cleanser contains 100 mg of Sodium Sulfacetamide and 20 mg of sulfur in a formulation containing: Aloe Vera Leaf, Butylated Hydroxytoluene, Camellia Oleifera Leaf, Cetyl Alcohol, Disodium Oleamido Monoethanolamine Sulfosuc cinate, Edetate Disodium, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylparaben, Peg-100 Stearate, Propylparaben, Sodium Cocoyl lsethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Water, Xanthan Gum. structure
Indications & Usage
INDICATIONS: Sulfacetamide Sodium and Sulfur Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
: Use once daily or as directed by your physician. Wet skin. Apply in a film to entire face, avoiding contact with eyes or mucous membranes. Wait 10 minutes or until dry. Rinse thoroughly with water and pat dry.
Warnings & Precautions
WARNINGS: Although rare, sensitivity to Sulfacetaminde Sodium 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
: Sulfacetamide Sodium and Sulfur Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfacetamide Sodium and Sulfur Cleanser is not to be used by patients with kidney disease.
Adverse Reactions
Although rare, Sulfacetamide Sodium may cause local irritation.
Storage & Handling
Store at 20°-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F). Brief exposure to temperatures up to 40° (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.
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