DESCRIPTION
id: 7a1735ff-968d-437e-83db-154b2b41fe66
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each gram of Sodium Sulfacetamide and Sulfur (sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 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:
CLINICAL PHARMACOLOGY
id: ca440b51-859b-41a7-ae80-8202cf2a054c
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
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.
INDICATIONS
id: a2816e47-6eb1-4b1c-936f-ffad1b092e8a
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS
id: b1ef194d-53bb-41d8-84e4-4fc7eaa03c43
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is not to be used by patients with kidney disease.
WARNINGS
id: 4793b05d-1f81-4759-98ad-b988d9bc40e4
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Although rare, sensitivity to sodium sulfacetamide 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.
Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF REACH OF CHILDREN.
PRECAUTIONS
id: 1ecf5034-7a23-4827-a411-74a4cc42306d
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
ADVERSE REACTIONS
id: 8dfc476a-36ed-42da-a759-4be7b36387aa
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION
id: b7febc3f-5b47-4e8e-af32-2be6b77c144a
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Wash affected areas with Sodium Sulfacetamide 10% and Sulfur 2% 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.
HOW SUPPLIED
id: e457886c-833b-4fc0-8dbe-245d5e08f99f
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is supplied in an 8 oz. (227 g) bottle, NDC 42582-800-08.
PRINCIPAL DISPLAY PANEL – 227 g Bottle Label
id: 1dc59bde-0796-4038-ae34-2012790cdf37
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 42582-800-08
Rx Only
SODIUM
SULFACETAMIDE 10%
AND SULFUR 2%
Cleanser
(sodium sulfacetamide 10%, sulfur 2%)
Net Wt. 8 oz. (227 g)
Bi-Coastal Pharma International LLC
