Label Changes for:

Cordran (flurandrenolide, USP) Lotion

July 2011

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

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

 

PRECAUTIONS

General
  • Pediatric patients may absorb proportionately larger amounts.....
Information for Patients
  • 2. Do not use Cordran Lotion on the face, underarms, or groin areas unless directed by your physician

ADVERSE REACTIONS

Postmarketing Adverse Reactions
  • The following adverse reactions have been identified during post approval use of flurandrenolide lotion. Because these reactions .....
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