Label: ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid
- NDC Code(s): 72476-482-86
- Packager: Retail Business Services, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 26, 2023
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- Official Label (Printer Friendly)
- TEP
- Active ingredients
- 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 daily 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
- Claims
- Dislcaimer
- Adverse reaction
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Principal display panel
CAREONE
Compare to the Active Ingredient in Crest Pro-Health™ Advanced Anticavity Fluoride Mouthwash*
ALCOHOL FREE
FLUORIDE MOUTHWASH
ANTICAVITY
FLUORIDE RINSE
VIOLET MINT FLAVOR
KILLS BAD BREATH GERMS
HELPS PREVENT CAVITIES
HELPS STRENGTHEN ENAMEL
CLEANS TEETH**
FRESHENS BREATH
IMPORTANT: Read directions for proper use
33.8 FL OZ (1.05 QT) 1L
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INGREDIENTS AND APPEARANCE
ALCOHOL-FREE ANTICAVITY
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-482 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHOSPHORIC ACID (UNII: E4GA8884NN) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-482-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/03/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/01/2013 Labeler - Retail Business Services, LLC (967989935) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(72476-482) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(72476-482)