DailyMed Label: Sodium Sulfacetamide 10% and Sulfur 5% Cleanser

DailyMed Label: Sodium Sulfacetamide 10% and Sulfur 5% Cleanser

2023

DailyMed Prescription

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser

sulfacetamide sodium and sulfur

Gabar Health Sciences Corp.

NDC: 82429-107

NDC: 82429-107

DESCRIPTION:  Each gram of Sodium Sulfacetamide and Sulfur (sodium sulfacetamide 10% w/w and sulfur 5% w/w) contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: aloe vera leaf extract, butylated hydroxytoluene, cetyl alcohol, disodium oleamido monoethanolamine 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, xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S·H 2 O 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 10% & Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

DOSAGE AND ADMINISTRATION Wash affected areas with Sodium Sulfacetamide 10%, and Sulfur 5% 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 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.

PRECAUTIONSFOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE General If irritation develops, use of this product should be discontinued and appropriate therapy instituted. Patients should be very 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 Sodium Sulfacetamide 9% & Sulfur 4.5% Wash. It is also 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. NURSING MOTHERS It is not known whether Sodium Sulfacetamide is excreted in human milk following topical use of Sodium Sulfacetamide 10% & Sulfur 5% Cleanser. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% & Sulfur 5% 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 10% & Sulfur 5% Cleanser is supplied in an 6oz. (170g) bottle (NDC 82429-107-06), 8oz. (227g) bottle (NDC 82429-107-08) and 12oz. (340g) bottle (NDC 82429-107-12) . Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 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 bottle 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 by: Gabar Health Sciences, Corp Atlanta, GA 30354 USA Rev 04/23

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.

PRINCIPAL DISPLAY PANEL - Bottle Label Rx only Sodium Sulfacetamide 10% & Sulfur 5% Cleanser SHAKE WELL BEFORE USE image description