Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 59779-213-44
- 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 May 24, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warning
- Keep out of reach of children
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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 the inside of cap); do not fill above 10 ML mark
- vigorously swish 10 millilters 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
- SPL UNCLASSIFIED SECTION
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Principal display panel
CVS HEALTH
Compare to the active ingredient in ACT Anticavity Fluoride Mouthwash*
Anticavity Fluoride Rinse
ALCOHOL FREE
- Helps prevent tooth decay
- Strengthens teeth
- Strong cavity protection
- Freshens breath
Mint Flavor
ADA Accepted
American Dental Association
Helps prevent cavities
Sealed with printed neckband for your protections. Do not use if broken or missing.
IMPORTANT: Read Directions for proper use.
18 FL OZ (532 mL)
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-213 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 water (UNII: 059QF0KO0R) sorbitol (UNII: 506T60A25R) MENTHOL (UNII: L7T10EIP3A) METHYL SALICYLATE (UNII: LAV5U5022Y) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BENZYL ALCOHOL (UNII: LKG8494WBH) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-213-44 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/19/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/19/2001 Labeler - CVS Pharmacy, Inc. (062312574) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(59779-213) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(59779-213)