Label Changes for:
Altabax (Retapamulin) Ointment
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Not for Systemic or Mucosal Use
- The efficacy and safety of ALTABAX on mucosal surfaces have not been established.