Label Changes for:

Lotrisone (clotrimazole and betamethasone dipropionate) Cream and Lotion

January 2008

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) -- January 2008

 

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.


Summary View

Sections Modified

ADVERSE REACTIONS

  • The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings...
    • ...capillary fragility (ecchymoses), and sensitization (local reactions upon repeated application of product)...

PATIENT PACKAGE INSERT

  • What are the possible side effects of Lotrisone Cream and Lotion?
    • ...fragile blood vessels, sensitization (local reactions upon repeated application of product)...
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