Label Changes for:

Ovide (malathion) 0.5% lotion

December 2011

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011

 

 

WARNINGS

  • Chemical burns including second-degree burns

Information for Patients

  • Burns and stinging sensations may occur when using Ovide lotion

 

ADVERSE REACTIONS

  • Other adverse reactions reported… including second-degree burns.
  • It is not known if Ovide Lotion has the potential to cause contact allergic sensitization.
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