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.
