Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
- NDC Code(s): 59779-004-77
- Packager: CVS Pharmacy, Inc
- 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 January 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warning
- 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 toothpaste
- remove cap
- pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
- 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
- Adverse reaction
-
principal display panel
CVS
Health
Compare to ACT Bubble Gum Blowout Anticavity Kids Fluoride Rinse*
Children's
ANTICAVITY FLUORIDE RINSE
- Helps prevent cavities
- Helps Strengthen Teeth
- Alcohol free
Bubblegum Flavor
ADA
Accepted
American
Dental
Association
Helps Prevent cavities
IMPORTANT: Read directions for proper use
Sealed with printed neckband for your protection
16.9 FL OZ (500 mL)
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INGREDIENTS AND APPEARANCE
ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-004 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 ANHYDROUS (UNII: 8NLQ36F6MM) 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) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-004-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/08/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/08/2004 Labeler - CVS Pharmacy, Inc (062312574) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(59779-004) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(59779-004)