Executive Summary

ANTICARIES MONOGRAPH LISTS THREE ACCEPTABLE ACTIVE INGREDIENTS: sodium fluoride, sodium monofluorophosphate and stannous fluoride. Four ingredients are currently designated not generally recognized as safe and effective for anticaries use: hydrogen fluoride, sodium carbonate, sodium monofluorophosphate (6% rinse) and sodium phosphate. The final rule adds as "nonmonograph" the ingredients: calcium sucrose phosphate, dicalcium phosphate dihydrate, disodium hydrogen phosphate, phosphoric acid, sodium dihydrogen phosphate, sodium dihydrogen phosphate monohydrate, and sodium phosphate, dibasic anhydrous reagent.