SODIUM SULFACETAMIDE

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 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: 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. chemical structure

: 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.

: 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.

: 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.

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.

SODIUM SULFACETAMIDE 10% CLEANSING GEL is incompatible with silver preparations.

Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (59ºF and 86ºF). [See USP, “Controlled Room Temperature.”] Protect from freezing and excessive heat.