Label Changes for:

Altabax (Retapamulin) Ointment

December 2012

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)

 

December 2012

 

WARNINGS AND PRECAUTIONS

Not for Systemic or Mucosal Use
  • The efficacy and safety of ALTABAX on mucosal surfaces have not been established.
 
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