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FDA Grants 510(k) Clearance to Prontosan

B. Braun's wound management gel available OTC.

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By: TOM BRANNA

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The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for B. Braun’s Prontosan Wound Management Gel for OTC use. Prontosan Wound Management Gel with PHMB (Polyhexanide), which was rolled out in 2009,was initially used in healthcare settings for cleaning wounds as well as moistening and lubricating absorbent wound dressings.

“Effective wound care management nolonger needs to be limited to within healthcare facility walls,” said Mike Kelly, director of marketing, infection control Ppoducts for B. Braun Medical Inc.

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 gelcontains PHMB and betaine.

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