Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is available in a 16 oz (454 g) bottle, NDC 82429-301-21.; PRINCIPAL DISPLAY PANEL - 454 g Bottle Label NDC 82429-301-21 Rx only For topical use only Not ophthalmic use Sodium Sulfacetamide 9% & Sulfur 4.5% Wash Gabar Health Sciences Corp. Net WT. 16oz. (454 g) PRINCIPAL DISPLAY PANEL
- HOW SUPPLIED Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is available in a 16 oz (454 g) bottle, NDC 82429-301-21.
- PRINCIPAL DISPLAY PANEL - 454 g Bottle Label NDC 82429-301-21 Rx only For topical use only Not ophthalmic use Sodium Sulfacetamide 9% & Sulfur 4.5% Wash Gabar Health Sciences Corp. Net WT. 16oz. (454 g) PRINCIPAL DISPLAY PANEL
Overview
Sodium Sulfacetamide is a sulfonamide with antibacterial with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, Sodium Sulfacetamide is N-[(4-aminophenyl) sulfony]-acetamide, monosodium salt, monohydrate. The structural formula is: Each mL of Sodium Sulfacetamide 9% & Sulfur 4.5% wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: aloe vera, fragrance, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl tau rate, sodium thiosulfate, stearyl alcohol, and xanthan gum. Chemical Structure
Indications & Usage
INDICATIONS Sodium Sulfacetamide 9% & Sulfur 4.5% Was 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 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 any other component of this preparation. Sodium Sulfacetamide 9% & Sulfur 4.5% Wash in not to be used by patients with kidney disease.
Adverse Reactions
Although rare, sodium sulfacetamide may cause local irritation.
Storage & Handling
STORAGE 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 MEDICATION OUT OF THE REACH OF CHILDREN
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