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.
There is currently no manufacturer warning information available for this drug.
OVACE
® Plus Cream 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.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram of OVACE
® Plus Cream (sodium sulfacetamide 10% w/w) contains 100 mg of sodium sulfacetamide in a vehicle consisting of benzyl alcohol, butylparaben, C13-14 isoparaffin, caprylic/capric triglyceride, cetyl alcohol, dimethicone, disodium EDTA, ethylparaben, glycerin, glyceryl stearate, laureth-7, methylparaben, PEG-100 stearate, phenoxyethanol, polyacrylamine, propylparaben, sodium thiosulfate, water and zinc oxide.
Sodium sulfacetamide is C
8H
9N
2NaO
3S·H
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.