- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PURE MOUTH LIQUID
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72875-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.02 g in 100 mL Inactive Ingredients Ingredient Name Strength POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72875-0001-1 11 mL in 1 POUCH; Type 0: Not a Combination Product 02/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/10/2019 Labeler - On On Co., Ltd. (695015695) Registrant - On On Co., Ltd. (695015695) Establishment Name Address ID/FEI Business Operations On On Co., Ltd. 695015695 label(72875-0001) , manufacture(72875-0001)