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U.S. Department of Health and Human Services

Safety

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Evoclin (clindamycin phosphate) Foam

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2012

 

Summary View

4 CONTRAINDICATIONS

  • including pseudomembranous colitis.... added

5 WARNINGS AND PRECAUTIONS

5.2 Irritation
  • Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritation or dermatitis occurs, clindamycin should be discontinued
  • Avoid contact of EVOCLIN Foam with eyes, mouth, lips, other mucous membranes or areas of broken skin....

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • colitis (including pseudomembranous colitis), and hemorrhagic diarrhea
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