Drug intelligence / Profile preview

ZuraGard

Development stage
Approved
Lead developer
Zurex Pharma
Modality
Small Molecules
Administration
Topical
01

Overview

ZuraGard is a topical preoperative skin preparation consisting of a 70% v/v isopropyl alcohol solution formulated with excipients including citric acid, methylene blue, methylparaben, purified water, and trolamine, and supplied in single-use sterile applicators in multiple fill sizes for small and large surgical fields.[1][2] It acts as a rapid, broad-spectrum antiseptic that reduces bacterial counts on intact skin prior to surgery, providing an alcohol-only alternative for patients who cannot receive chlorhexidine- or iodine-containing products, and was developed and approved via an NDA by Zurex Pharma using the 505(b)(2) pathway with ChloraPrep as the reference product.[1][5][7] Clinical studies demonstrated non-inferiority to chlorhexidine/isopropyl alcohol combinations for log10 reductions in skin flora and acceptable local tolerability, with labeling emphasizing external use, flammability precautions, and avoidance on open wounds, meninges, or for lumbar puncture.[1][2]

Brand names
ZuraGard
Other names
ZurexPrep clear

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