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U.S. Department of Health and Human Services

Safety

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Duac Topical Gel (clindamycin, 1% - benzoyl peroxide, 5%) July 2008


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

PRECAUTIONS

  • Information for Patients
    • ...Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue use and contact their physician immediately.

ADVERSE REACTIONS

  • ...Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with Duac Topical Gel...