Label: ANTICAVITY RINSE- sodium fluoride mouthwash
- NDC Code(s): 79481-0201-1
- Packager: Meijer Distribution, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 31, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- TEP
- Active ingredient
- Purpose
- Use
- Warnings
- Keep out of reach of children.
-
Directions
Adults and children 6 years of age and older:
- use once a day after brushing your teeth with a toothpaste
- vigorously swish 10 milliliters 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
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
Children under 6 years of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- Questions?
- Disclaimer
- Adverse reactions
- Principal display panel
-
INGREDIENTS AND APPEARANCE
ANTICAVITY RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0201 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) EDETATE DISODIUM (UNII: 7FLD91C86K) MEPREDNISONE DISODIUM PHOSPHATE (UNII: W80C977F6O) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE (UNII: SE337SVY37) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-0201-1 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 07/14/2021 Labeler - Meijer Distribution, Inc. (006959555) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(79481-0201) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(79481-0201)
