Sumadan Wash Recall
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Questions & Answers
Side Effects & Adverse Reactions
Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
There is currently no drug history available for this drug.
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each mL of Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: butylated hydroxytoluene, C12-15 alkyl benzoate, caprylyl glycol, cetyl alcohol, cholesterol, chrysanthemum dendranthema, dimethicone, disodium oleamido MIPA sulfosuccinate, edetate disodium, ethylene brassilate, glyceryl stearate, hexylene glycol, lemon oil, magnesium aluminum silicate, magnesium chloride, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, niacinamide, nonoxynol-20, octoxynol-5, purified water, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium cocoyl isotheionite, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum.