Application Nr Approved Date Route Status External Links
NDA021669 2005-04-25 None OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Clinical Pharmacology Peridex Oral Rinse Provides Antimicrobial Activity During Oral Rinsing. The Clinical Significance Of Peridex Oral Rinse's Antimicrobial Activities Is Not Clear. Microbiological Sampling Of Plaque Has Shown A General Reduction Of Counts Of Certain Assayed Bacteria, Both Aerobic And Anaerobic, Ranging From 54-97% Through Six Months Use. Use Of Peridex Oral Rinse In A Six Month Clinical Study Did Not Result In Any Significant Changes In Bacteria Resistance, Overgrowth Of Potentially Opportunistic Organisms Or Other Adverse Changes In The Oral Microbial Ecosystem. Three Months After Peridex Oral Rinse Use Was Discontinued, The Number Of Bacteria In Plaque Had Returned To Baseline Levels And Resistance Of Plaque Bacteria To Chlorhexidine Gluconate Was Equal To That At Baseline.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATE ZINC1531008

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