Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream is available in 2 oz (57 g) tubes, NDC 42192-149-02 and SSS 10% - 5% (Sodium Sulfacetamide - Sulfur) Emollient Cream in 1 oz (28 g) tubes, NDC 42192-139-01.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 28 g carton label NDC 42192-139-01 SSS 10% - 5% (Sodium Sulfacetamide - Sulfur) Emollient Cream Rx Only 1 oz (28 g) Acella PHARMACEUTICALS, LLC Container; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 57 g carton label 42192-149-02 Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream Net wt. 2 oz (57 g) Acella PHARMACEUTICALS, LLC Container
- HOW SUPPLIED: Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream is available in 2 oz (57 g) tubes, NDC 42192-149-02 and SSS 10% - 5% (Sodium Sulfacetamide - Sulfur) Emollient Cream in 1 oz (28 g) tubes, NDC 42192-139-01.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 28 g carton label NDC 42192-139-01 SSS 10% - 5% (Sodium Sulfacetamide - Sulfur) Emollient Cream Rx Only 1 oz (28 g) Acella PHARMACEUTICALS, LLC Container
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 57 g carton label 42192-149-02 Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream Net wt. 2 oz (57 g) 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 gram of Sodium Sulfacetamide 10% Sulfur 5% Emollient Cream contains 100 mg of Sodium Sulfacetamide, USP and 50 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. Structural Formula
Indications & Usage
INDICATIONS: Sodium Sulfacetamide 10% Sulfur 5% Emollient 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 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 10% Sulfur 5% Emollient Cream is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.Sodium Sulfacetamide 10% Sulfur 5% Emollient 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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