displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each gram of SODIUM SULFACETAMIDE 10% – SULFUR 2% CLEANSER
(sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a mild aqueous based cleansing vehicle containing BHT, cetyl alcohol, disodium edta, glyceryl stearate, lactic acid, magnesium aluminum silicate, methylparaben, PEG-100 stearate, petrolatum, propylparaben, purified water, sodium C14-16 olefin sulfonate, sodium thiosulfate, stearyl alcohol, and xanthan gum.
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C
3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
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.
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
SODIUM SULFACETAMIDE 10% – SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
SODIUM SULFACETAMIDE 10% – 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% – SULFUR 2% CLEANSER is not to be used by patients with kidney disease.
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.
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.
DOSAGE AND ADMINISTRATION:
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Wash affected areas with SODIUM SULFACETAMIDE 10% – SULFUR 2% CLEANSER 1 to 2 times daily or as directed by a 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.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
SODIUM SULFACETAMIDE 10% – SULFUR 2% CLEANSER is supplied in an 8 oz. (227 g) bottle, NDC 42192-147-08.
PRINCIPAL DISPLAY PANEL – 227 g Bottle Label
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Sodium Sulfacetamide 10%
SHAKE WELL BEFORE USE
8 oz. (227 g)