Pill Identifier App

Label Changes for:

Evoclin (clindamycin phosphate) Foam

January 2012

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, 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 2012

 

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
Hide
(web2)