CareFusion announced that the FDA has approved a labeling update with reduced dry times as part of the directions for use on certain ChloraPrep products.
ChloraPrep products contain 2% w/v chlorhexidine gluconate and 70% w/v isopropyl alcohol. They are indicated for the preparation of the patient’s skin prior to surgery and for the reduction of bacteria that potentially can cause skin infection.
The labeling update applies to various CareFusion ChloraPrep products used in skin preparation, including Sepp, Frepp, Single and Triple Swabsticks. These applicators are no longer labeled for electrocautery procedures and have a reduced dry time on dry surgical sites of 30 seconds and a dry time on moist surgical sites of one minute.
In addition, the ChloraPrep 3mL applicators have updated labeling to include dry time change to 30 seconds for dry sites and one minute for moist sites for procedures not using an ignition source.
Labeling for the ChloraPrep 10.5mL and 26mL has remained the same.
For more information call (888) 876-4287 or visit CareFusion.com.