displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each mL of SODIUM SULFACETAMIDE 10% CLEANSING GEL contains 100 mg of sodium sulfacetamide, USP in a formulation containing Citric acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate, Methylparaben, PEG-6 Caprylic/Capric Glycerides, PEG-60 Almond Glycerides, PEG-150 Pentaerythrityl Tetrastearate, Polysorbate 60, Sodium Lauryl Sulfate, Sodium Thiosulfate, Water, Xanthan Gum.
Sodium sulfacetamide is C
2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of SODIUM SULFACETAMIDE 10% CLEANSING GEL when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.
INDICATIONS AND USAGE:
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
SODIUM SULFACETAMIDE 10% CLEANSING GEL is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
SODIUM SULFACETAMIDE 10% CLEANSING GEL is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
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 THE REACH OF CHILDREN.
displayName: WARNINGS AND PRECAUTIONS SECTION
FDA Article Code: 43685-7
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If SODIUM SULFACETAMIDE 10% CLEANSING GEL produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see
WARNINGS). Call your doctor for medical advice about side effects.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
The oral LD50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately.
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manifestations: Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center or your doctor.
DOSAGE AND ADMINISTRATION:
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Seborrheic dermatitis including seborrhea sicca – Wash affected areas twice daily (morning and evening), 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 working into a full lather, rinse thoroughly, pat dry and repeat after 10 to 20 seconds. Rinsing with plain water will remove any excess medication. Repeat application as described for 8 to 10 days. lf skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. Regular shampooing following SODIUM SULFACETAMIDE 10% CLEANSING GEL is not necessary, but the hair should be shampooed at least once a week. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of SODIUM SULFACETAMIDE 10% CLEANSING GEL should be reinitiated as at the beginning of treatment.
Secondary cutaneous bacterial infections – 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. Rinsing with plain water will remove any excess medication. Repeat application as described for 8 to 10 days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
SODIUM SULFACETAMIDE 10% CLEANSING GEL is available in a 12 fl. oz. (355 mL) bottle, NDC 42192-146-12.
PACKAGE LABEL – 12 fl. oz. (355 mL) bottle
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
For External Use Only
12 fl. oz. (355 mL)