Sodium Sulfacetamide Shampoo Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
This product 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.
There is currently no drug history available for this drug.
Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, citric acid anhydrous, cocamide MEA, cocamidopropyl betaine, ethylene glycol distearate, fragrance, magnesium aluminum silicate, methylparaben, PEG-150 distearate, propylparaben, purified water, sodium chloride, sodium laureth sulfate and titanium dioxide (and) mica.
Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C8H9N2NaO3S·H2O 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.