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...