Label Changes for:

ChloraPrep [chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v)] solution [OTC]

March 2010

Changes have been made to the WARNINGS sections of the safety label.

  • ChloraPrep One-Step 1.0-mL applicator
  • ChloraPrep One-Step 1.5-mL Frepp applicator
  • ChloraPrep One-Step 3-mL applicator
  • ChloraPrep One-Step 10.5-mL applicator
  • ChloraPrep One-Step 26-mL applicator
  • ChloraPrep One-Step Sepp 0.67-mL applicator 
  • ChloraPrep One-Step 1.75-mL single swabstick applicator 
  • ChloraPrep One-Step 5.25-mL triple swabstick applicators
  • ChloraPrep With Tint (FD&C Green #3) 3-mL applicator 
  • ChloraPrep With Tint (FD&C Green #3) 10.5-mL applicator
  • ChloraPrep With Tint (FD&C Green #3) 26-mL applicator
  • ChloraPrep With Tint (FD&C Yellow #6) 3-mL applicator 
  • ChloraPrep With Tint (FD&C Yellow #6) 10.5-mL applicator 
  • ChloraPrep With Tint (FD&C Yellow #6) 26-mL applicator

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010

DRUG FACTS

WARNING

  • Flammable, keep away from fire or flame
  • Solution contains alcohol and gives off flammable vapors
  • Wet hair is flammable
Hide
(web4)