Drug Catalog - Product Detail
SODIUM SULFACETAMIDE W/SULFUR EMOLLIENT CREAM 10/2% CRM 2OZ
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 42192-0150-02 | ACELLA PHARMACEUTICALS | 57 | 10-2% | CREAM |
PACKAGE FILES
Generic Name
SULFACETAMIDE SODIUM AND SULFUR
Substance Name
SULFACETAMIDE SODIUM
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
Description
DESCRIPTION: 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
How Supplied
HOW SUPPLIED: Sodium Sulfacetamide 10% Sulfur 2% Cream is available in 2 oz (57 g) tubes, 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.
Indications & Usage
INDICATIONS: Sodium Sulfacetamide 10% Sulfur 2% Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage and Administration
DOSAGE AND 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.