DailyMed Label: Sodium Sulfacetamide 9.8%, Sulfur 4.8%

DailyMed Label: Sodium Sulfacetamide 9.8%, Sulfur 4.8%

2022

DailyMed Prescription

Sodium Sulfacetamide 9.8%, Sulfur 4.8%

Sodium Sulfacetamide, Sulfur

Bi-Coastal Pharma International LLC

NDC: 42582-801

NDC: 42582-801

DESCRIPTION:  Each gram of Sodium Sulfacetamide and Sulfur (sodium sulfacetamide 9.8% w/w and sulfur 4.8% w/w) contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: 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, xantham gum.Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C8H9N2NaO3S∙H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl] acetamide, monosodium salt, monohydrate. The structural formula is: image description

INDICATIONS: Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

DOSAGE AND ADMINISTRATION: Wash affected areas with Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser one to two times 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 drying occurs, it may be controlled by rinsing cleanser off sooner or using cleanser less often.

CONTRAINDICATIONS: Sodium Sulfacetamide 9.8% and 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% and Sulfur 4.8% Cleanser is not to be used by patients with kidney disease.

PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 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. 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 SodiumNSulfacetamide 9.8% and Sulfur 4.8% Cleanser. It is also not known whether SodiumNSulfacetamide 9.8% and Sulfur 4.8% Cleanser can cause fetal harm when administered to aNpregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9.8% and SulfurN4.8% Cleanser should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether sodium sulfacetamide is excreted in human milk following topicaI use of Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser. However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 has not been established.

HOW SUPPLIED: Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser is supplied in an 8 oz. (227 g) bottle, NDC 42582-801-11. Store at 25°C (77°F); excursions permitted to between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Note: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep tube or packet tightly closed. Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches. Manufactured for: Bi-Coastal Pharma International LLC Red Bank, New Jersey 07701 USA 6/15

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 unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

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