Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Sodium Sulfacetamide 10% Sulfur 2% Cream is available in 2 oz (57 g) bottles, NDC 42192-150-02. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature] 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.; PRINCIPAL DISPLAY PANEL - 57 g Bottle Label NDC 42192-150-02 Rx Only Sulfacetamide Sodium 10% Sulfur 2% Cream Net wt. 2 oz (57 g) Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - 57 g Bottle Label
- HOW SUPPLIED: Sodium Sulfacetamide 10% Sulfur 2% Cream is available in 2 oz (57 g) bottles, NDC 42192-150-02. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature] 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.
- PRINCIPAL DISPLAY PANEL - 57 g Bottle Label NDC 42192-150-02 Rx Only Sulfacetamide Sodium 10% Sulfur 2% Cream Net wt. 2 oz (57 g) Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - 57 g Bottle Label
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 10% Sulfur 2% Cream contains 100 mg of Sodium Sulfacetamide and 20 mg of Sulfur in a base containing BHT, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol,Disodium EDTA, Ethylhexyl Palmitate, Ethylparaben, Fragrance, Glyceryl Monostearate SE, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Sodium Thiosulfate and Xanthan Gum. Chemical Structure
Indications & Usage
INDICATIONS: Sodium Sulfacetamide 10% Sulfur 2% Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
: Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily or as directed by a physician. To minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician.
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.
Contraindications
: Sodium Sulfacetamide 10% Sulfur 2% Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% Sulfur 2% Cream 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° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]
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