- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
DOSAGE & ADMINISTRATION
Adults and children 12 years of age and older:
• Use twice daily after brushing your teeth with a toothpaste
• Vigorously swish 10mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
• Do not swallow the rinse
• Do not eat or drink for 30 minutes after rinsing
• Supervise children as necessary until capable of suing without supervisorChildren under 12 years of age: consult a dentist or doctor
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OLIDENTAL GARGLE
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70417-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.06 mg in 300 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALLANTOIN (UNII: 344S277G0Z) XYLITOL (UNII: VCQ006KQ1E) STEVIOSIDE (UNII: 0YON5MXJ9P) ACETIC ACID (UNII: Q40Q9N063P) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM ACETATE (UNII: 4550K0SC9B) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) SODIUM BENZOATE (UNII: OJ245FE5EU) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SACCHARIN SODIUM (UNII: SB8ZUX40TY) LEVOMENTHOL (UNII: BZ1R15MTK7) PROPOLIS WAX (UNII: 6Y8XYV2NOF) LEMON OIL (UNII: I9GRO824LL) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70417-001-01 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/20/2016 Labeler - AJU PHARM CO., LTD. (687982405) Registrant - AJU PHARM CO., LTD. (687982405) Establishment Name Address ID/FEI Business Operations AJU PHARM CO., LTD. 687982405 manufacture(70417-001)