Label: ANTICAVITY RINSE- sodium fluoride mouthwash
- NDC Code(s): 55319-004-44
- Packager: Family Dollar Services, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 8, 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 year 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 year of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- Disclaimer
- Adverse reaction
-
Principal display panel
IMPORTANT: read directions for proper use.
sealed with printed neckband for your protection.
Do not use if band around cap is broken or missing.
FAMILY WELLNESS™
Compare to ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse*
Children's ANTICAVITY FLUORIDE RINSE
- Strong cavity protection
- Alcohol free
- Helps strengthen teeth
- Helps prevent cavities
BUBBLEGUM FLAVOR
18 FL OZ (1.12 PT) 532 mL
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INGREDIENTS AND APPEARANCE
ANTICAVITY RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-004 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 ANHYDROUS (UNII: 8U5D034955) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) D&C RED NO. 33 (UNII: 9DBA0SBB0L) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE (UNII: SE337SVY37) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-004-44 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/02/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 08/02/2011 Labeler - Family Dollar Services, Inc (024472631) Registrant - Vi Jon, LLC (088520668) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(55319-004) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(55319-004)