Label Changes for:
Lotrisone (clotrimazole and betamethasone dipropionate) Cream and Lotion
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.|
- 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)...