DailyMed Label: Sodium Sulfacetamide 10 Sulfur 5 Cleanser

DailyMed Label: Sodium Sulfacetamide 10 Sulfur 5 Cleanser

2024

DailyMed Prescription

Sodium Sulfacetamide 10 Sulfur 5 Cleanser

Sulfacetamide Sodium and Sulfur

Acella Pharmaceuticals, LLC

NDC: 42192-136

NDC: 42192-136

NDC: 42192-136

DESCRIPTION: Each mL of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in a formulation containing butylated hydroxytoluene, cetyl alcohol, disodium EDTA, glyceryl stearate, PEG 100 stearate, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, white petrolatum 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: Chemical Structure

INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

DOSAGE AND ADMINISTRATION: Apply Sodium Sulfacetamide 10% - Sulfur 5% Cleanser 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 full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 10% - Sulfur 5% Cleanser sooner or using less often.

CONTRAINDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is not to be used by patients with kidney disease.

General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician. Carcinogenesis, Mutagenesis and Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential. PREGNANCY: Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% - Sulfur 5% Cleanser. It is not known whether Sodium Sulfacetamide 10% - Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 5% Cleanser should be given to a pregnant woman only if clearly needed.

HOW SUPPLIED:  Sodium Sulfacetamide 10% - Sulfur 5% Topical Suspension is available in 6 oz (170.3 g) bottles, NDC 42192-136-06, 8 oz (227 g) bottles, 42192-136-08 and 12 oz (340.2 g) bottles, NDC 42192-136-12. Store at 15° - 25°C (59° - 77°F). Protect from freezing. 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.

CLINICAL PHARMACOLOGY: The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

NDC 42192-136-06 Sodium Sulfacetamide 10% - Sulfur 5% Cleanser Rx Only SHAKE WELL BEFORE USE 6 oz (170.3 g) Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label