BD ChloraPrep™ Applicators with Sterile Solution

<p>A rapid-acting and persistent preoperative skin preparation. Its proven formulation is available in six unique applicators designed for procedures ranging from peripheral IV insertion to major surgery.</p>

<p>Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v.</p>

<p>Yes. After submitting a new drug application (NDA) to the Food and Drug Administration (FDA), ChloraPrep preoperative skin preparation received FDA approval in 2000.</p>

<p>When seeking Food and Drug Administration (FDA) approval for an over-the-counter antiseptic, all manufacturers of chlorhexidine-based solutions are required to submit a new drug application (NDA). The review of a NDA by the FDA includes evaluation of clinical, manufacturing and labeling information to assure the product is safe and effective.</p> <p>Alcohol and iodophors were identified by the FDA as "generally recognized as safe and effective" (GRASE) and are included in the tentative final monograph from the FDA. As a result, manufacturers of alcohol, iodophors and iodine-based solutions can market products without submitting efficacy and safety data and product labeling to the FDA for review prior to marketing and selling their products.</p>

<p>ChloraPrep preoperative skin preparation meets the Centers for Disease Control and Prevention (CDC) Guidelines for the Prevention of Intravascular Catheter-Related Infections, published in 2002. The guidelines state to "clean skin with a > 0.5% chlorhexidine preparation with alcohol before central venous catheter and peripheral arterial catheter."</p>

<p>The use of a 2% chlorhexidine-based preparation for cutaneous antisepsis is classified as a Category 1A recommendation—the highest level of recommendation the Centers for Disease Control and Prevention (CDC) bestows. A Category 1A recommendation is clean skin with a > 0.5% chlorhexidine preparation with alcohol before central venous catheter and peripheral arterial catheter.</p>

<p>The tint process for ChloraPrep Scrub Teal™ and Hi-Lite Orange™ tints is a patented technology that adds color to the solution as it enters the sponge pad. When applied to the skin, each tint allows for easy visualization of the prepped area. Unlike iodine-based preps, which are brown, Scrub Teal and Hi-Lite Orange tints are easy to see when applied to a variety of skin tones.</p> <p>The dyes in Scrub Teal and Hi-Lite Orange tints are Food, Drug and Cosmetic (FD&C) Green #3 and Yellow #6 dyes, and have been "generally recognized as safe" (GRAS) by the Food and Drug Administration (FDA). For an ingredient to be listed as GRAS, extensive safety testing is conducted, reviewed and accepted. FD&C Green #3 is a common colorant used in many applications throughout the healthcare field (e.g., eye angiography and screening for ocular dryness, routine lab testing, dye injections, histological/cytological stains for cancer screening of tissues). FD&C Green #3 and Yellow #6 were found to be stable when combined with the 2% chlorhexidine gluconate/70% isopropyl alcohol ChloraPrep formulation, which offers proven, stable and uncompromised chlorhexidine-based solutions.</p>

<p>Yes. Chlorhexidine gluconate is highly recommended by at least 18 organizations and initiatives, with 11 specifically advocating a 2% formulation.</p>

<p>The tint process for ChloraPrep Scrub Teal™ and Hi-Lite Orange™ tints is a patented technology that adds color to the solution as it enters the sponge pad. When applied to the skin, each tint allows for easy visualization of the prepped area. Unlike iodine-based preps, which are brown, Scrub Teal and Hi-Lite Orange tints are easy to see when applied to a variety of skin tones.</p> <p>The dyes in Scrub Teal and Hi-Lite Orange tints are Food, Drug and Cosmetic (FD&C) Green #3 and Yellow #6 dyes, and have been "generally recognized as safe" (GRAS) by the Food and Drug Administration (FDA). For an ingredient to be listed as GRAS, extensive safety testing is conducted, reviewed and accepted. FD&C Green #3 is a common colorant used in many applications throughout the healthcare field <em>(e.g., eye angiography and screening for ocular dryness, routine lab testing, dye injections, histological/cytological stains for cancer screening of tissues).</em> FD&C Green #3 and Yellow #6 were found to be stable when combined with the 2% chlorhexidine gluconate/70% isopropyl alcohol ChloraPrep formulation, which offers proven, stable and uncompromised chlorhexidine-based solutions.</p>