Label: ANTICAVITY- sodium fluoride mouthwash
- NDC Code(s): 41163-581-86
- Packager: United Natural Foods, Inc. dba UNFI
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 16, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- Keep out of reach of children.
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Directions
Adults and children 6 years of age and older:
- use twice a day after brushing your teeth with a toothpaste
- vigorously swish 10 mL (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
- 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
- Inactive ingredients
- Tamper Evident Statement
- Disclaimer
- Adverse reaction
- Principal panel display
-
INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-581 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE (UNII: SE337SVY37) POLYSORBATE 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-581-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 10/26/2020 Labeler - United Natural Foods, Inc. dba UNFI (943556183) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(41163-581) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(41163-581)