FDA Grants 510(k) Clearance for Ready-to-use Prontosan® Wound Management Gel as an OTC Providing Easy Accessibility to Patients
Bethlehem, Pa. – January 10, 2011 – In its continued effort to advance best practices in wound care management, B. Braun Medical Inc. (B. Braun) announced today that Prontosan® Wound Management Gel with PHMB (Polyhexanide), a product used in the healthcare setting for cleaning wounds as well as moistening and lubricating absorbent wound dressings, is now available for over-the-counter (OTC) use. The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Prontosan® Wound Management Gel for OTC use in November 2010.
“Effective wound care management no longer needs to be limited to within healthcare facility walls,” said Mike Kelly, Director of Marketing, Infection Control Products for B. Braun Medical Inc. “The 510(k) clearance for over-the-counter use of Prontosan® Wound Management Gel advances B. Braun’s commitment to infection prevention, helping to provide solutions that positively impact patients’ care – in a physician’s office, acute care setting or in a patient’s home.”
Prontosan® aids in the thorough removal of dirt and debris from chronic wounds, skin ulcers and abrasions, even when surfaces are difficult to access (i.e. skin folds, fissures and wound pockets), and can be used to cleanse and soften encrusted wound coatings.
The ready-to-use gel contains PHMB and Betaine, the surfactant for the cleansing and moistening of wounds. PHMB has quickly gained popularity among healthcare professionals as a wound irrigation cleanser. Its non-toxic and biocompatible formula offers excellent skin tolerance.
“Since Prontosan® Wound Management Gel no longer requires a prescription, physicians can rest assured that patients will have access to the easy-to-use wound care product after they are discharged,” said David Armstrong, DPM, MD, PhD, Professor of Surgery, University of Arizona.
With a shelf life of 28 days after opening, Prontosan® Wound Management Gel promotes the release of fibrin coatings and residue from wound coatings, and inhibits microorganisms from developing in the product. The gel’s PVC-free and DEHP-free product containers also make it environmentally friendly. Prontosan® was originally made available for physician-only use by B.Braun in the fall of 2009.
For more information about Prontosan® Wound Gel with PHMB (Polyhexanide), please call: 1-800-227-2862. To order Prontosan® online, visit www.starmedical-dme.com.
About B. Braun
B. Braun is a leading manufacturer of infusion therapy and pain management products with an environmentally-friendly focus. Guided by the company’s “Sharing Expertise®” philosophy, B.Braun addresses the critical issues of infection prevention, medication safety and environmental responsibility by promoting best practices that help clinicians reduce medication errors, prevent healthcare-acquired infections (HAIs) and achieve sustainability objectives.
Consistently recognized by Frost & Sullivan and KLAS for its medical technology and support services, B. Braun employees share their knowledge with colleagues and customers to improve working processes in hospitals and medical practices and to enhance the safety of patients and healthcare professionals. For more information, call 800-227-2862, e-mail us at firstname.lastname@example.org or visit B. Braun at www.bbraunusa.com.