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cal site, which could enhance the activity and residual effect of CHG.
Based on the collective evidence, this practice remains an unresolved
issue and warrants additional generalizable, high-quality research to
confirm the benefit of CHG-impregnated cloths for prevention of sur-
gical site infection.
1
FDA Categories of
Patient Pre-operative Skin Preparations
1
S U R G I C A L S K I N A S E P S I S
Active Ingredient Category
Benzalkonium chloride IIIE
Chlorhexidine gluconate New drug
Chloroxylenol IIIE
Hexachlorophene II
Iodine tincture USP I
Iodine topical solution USP I
Povidone-iodine 5% to 10% I
Triclosan IIIE
Iodine Povacrylex/Isopropyl Alcohol
2
New Drug
2
E= Effectiveness
References
1. US Food and Drug Administration. Tentative Final Monograph for
Healthcare Antiseptic Drug Products
proposed rule. Fed Regist. 1994;59(116):31402-31452.
2. US Food and Drug Administration. New Drug Application (NDA) #21-586.
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