Get an alert when a recall is issued.
Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sulfacetamide sodium 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.
There is currently no manufacturer warning information available for this drug.
Sodium Sulfacetamide-Sulfur 10%/5% Cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Each gram of Sodium Sulfacetamide-Sulfur 10%/5% Cleanser contains 100 mg of sulfacetamide sodium, USP and 50 mg of precipitated sulfur, USP in a vehicle consisting of: aloe vera leaf extract, butylated hydroxytoluene, camellia oleifera 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, and xanthan gum.
Sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sulfacetamide sodium, USP is C8H9N2NaO3S·H2O with molecular weight of 254.24. Chemically, sulfacetamide sodium, USP is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Sulfacetamide sodium, USP 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.