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U.S. Department of Health and Human Services


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Silvadene (silver sulfadiazine) Cream

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)


March 2013

Summary View


  • ...dermatologic and allergic reactions, including life-threatening cutaneous reactions [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and exfoliative dermatitis]