SODIUM SULFACETAMIDE 10% WASH

Rx Only For External Use Only Not For Ophthalmic Use. DESCRIPTION Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: Butylated hydroxytoluene, Citric acid, Cetyl alcohol, Cocamidopropyl betaine, Disodium EDTA, Glycerin, Glyceryl stearate SE, PEG-100 stearate, Phenoxyethanol, Purified water, Sodium laureth sulfate, Sodium thiosulfate, Stearyl alcohol, Triacetin, Xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S · H 2 O with molecular weight of 254.24. Chemically. sodium sulfacetamide 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. Structure

INDICATIONS Sodium Sulfacetamide 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.

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 above for 8 to 10 days or as directed by your physician. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. Regular shampooing following the use of f this product 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 this product should be reinitiated as at the beginning of treatment.

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

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.

This product is incompatible with silver preparations.

STORAGE 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). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.