CleanCare™ Hand Soaps, Sanitizers and Lotions - Cardinal Health

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Summary of Efficacy Studies for CleanCare Medicated Soaps For complete details and methodologies for any of these studies, please contact your Cardinal Health sales representative. Kill times: CleanCare 0.3% Triclosan Average counts per mL (Log10)/percent reduction for time period Organism Tested 0 seconds 15 seconds 30 seconds 60 seconds Inoculum Escherichia coli 6.6128 (
In Vivo Glove Juice Antimicrobial Efficacy Study: Exidine® 2% CHG Summary This study was performed per methodology specified by the FDA Tentative Final Monograph (TFM) Protocol for Healthcare Antiseptic Drug Products (21 CFR Parts 333 and 369). Test subjects scrubbed for 1.5 minutes with about 8mL of product without a brush and rinsed for 30 seconds. They repeated this process and dried thoroughly. Immediate, persistent and residual antimicrobial effects were then measured. Results The test product, Exidine® solution with 2% CHG, produced significant immediate log10 reductions of 1.56 on test day one, 2.17 on test day two and 3.28 on test day five. On these test days, microorganism populations recovered in the three-hour and sixhour samples remained below the baseline populations. These reductions meet and exceed the requirements of the FDA’s TFM for Surgical Hand Scrub products. See graph to right. Glove Juice Sampling Study: CleanCare 0.3% Triclosan Summary 5mL aliquots of approximately 108 S. marcescens was pipetted onto subjects’ hands. After a oneminute air-dry, a baseline sample level was established, followed by a hand wash with Ivory® liquid soap. This inoculation/wash procedure was repeated 10 times with a minimum of five minutes between applications. A transient microorganism sampling of the hands was performed after inoculation/product wash cycles 1, 3, 7 and 10, using the Glove Juice Sampling procedure. 3.5 3 2.5 2 1.5 1 0.5 0 Log 10 reductions of Exidine Solution with 2% CHG Day 1 Day 2 Day 5 TFM Exidine® 2% CHG FDA’s Requirements Exidine® Solution Sample for Surgical Hand TFM with 2% CHG Log 10 reductions Test product/Log 10 reductions Day 1, Immediate 1* 1.56 Day 1, 3 Hour 0.76 Day 1, 6 Hour 0.55 Day 2, Immediate 2 2.17 Day 2, 3 Hour 1.28 Day 2, 6 Hour 0.87 Day 5, Immediate 3 3.28 Day 5, 3 Hour 2.54 Day 5, 6 Hour 2.05 * The bacterial cell count does not exceed the baseline within six hours on the first day. Mean Log (Base 10) Mean Log Reduction Results Bacterial Populations From Baseline Baseline 10.57 Wash #1 7.30 3.27 Wash #3 7.49 3.08 Wash #7 7.52 3.05 Wash #10 7.26 3.31 www. cardinalhealth.com/mps 7
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CleanCare™ Hand Soaps, Sanitizers and Lotions - Cardinal Health

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