Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is supplied in a 10 oz (285 g) bottle (NDC 42192-156-10).; NDC 42192-156-10 Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser Rx Only Net Wt. 10 oz (285 g) Acella Pharmaceuticals, LLC label.jpg
- HOW SUPPLIED Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is supplied in a 10 oz (285 g) bottle (NDC 42192-156-10).
- NDC 42192-156-10 Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser Rx Only Net Wt. 10 oz (285 g) Acella Pharmaceuticals, LLC label.jpg
Overview
Each gram of Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser contains 98 mg of Sodium Sulfacetamide and 48 mg of Sulfur in a formulation containing Aloe Barbadensis (Aloe Vera) Leaf Extract, Butylated Hydroxytoluene, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl Alcohol, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium, Fragrance, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Propylparaben, Purified Water, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol and Xanthan Gum. 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: structure.jpg
Indications & Usage
INDICATIONS Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10 to 20 seconds, working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing off sooner or using less frequently.
Warnings & Precautions
WARNINGS Although rare, sensitivity to sodium sulfonamide 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 9.8% - Sulfur 4.8% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9.8% - Sulfur 4.8% Cleanser is not to be used by patients with kidney disease.
Adverse Reactions
Although rare, sodium sulfacetamide may cause local irritation.
Storage & Handling
STORAGE Store at 20º to 25ºC (68º to 77ºF), excursions permitted between 15º and 30ºC (between 59º and 86ºF). [See USP, “Controlled Room Temperature.”] Protect from freezing and excessive heat. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein. MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30022 1-800-541-4802 Rev. 0916-04
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