Label Changes for:

Lotrisone (clotrimazole and betamethasone dipropionate) Cream and Lotion

May 2009

Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2009

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

ADVERSE REACTIONS

  • telangiectasia

Patient Information Leaflet

  • What are the possible side effects of Lotrisone Cream and Lotion?

    ...fragile blood vessels, spider veins, sensitization (local reactions upon repeated application of product), change in skin color...

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