Label: ANTICAVITY- sodium fluoride rinse

  • 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 April 25, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Sodium fluoride 0.02% (0.01% w/v fluoride ion)

  • Purpose

    Anticavity rinse

  • Use

    aids in the prevention of dental cavities

  • Warning

    For this product

  • Keep out of Reach of Children

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 6 years of age and older:

    • use twice daily after brushing your teeth with a toothpaste
    • vigorously swish 10 mL 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

    • store at room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
    • cold weather may temporarily cloud this product
  • Inactive ingredients

    water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

    This product is not intended to replace brushing or flossing

    Distributed by:

    CVS Pharmacy Inc.

    One CVS Drive

    Woonsocket, RI 02895

    (c)2021 CVS/pharmacy

    CVS.com

    1-800-SHOP CVS

    CVS Quality money back guarantee

  • Principal display panel

    CVS Health

    Compare to Listerine Total Care Zero Anticavity Mouthwash*

    Alcohol Free

    Anticavity Fluoride

    Mouthwash

    SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPCAL SOLUTION

    6 Benefits:

    • Restores enamel
    • Helps prevent cavities
    • Cleans the entire mouth
    • Kills bad breath germs
    • Strengthens teeth
    • Freshens breath
    • Fresh mint

    Sealed with printed neckband for your protection. Do not use if broken or missing.

    IMPORTANT: read directions for proper use

    1L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-548
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    sorbitol (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    THYMOL (UNII: 3J50XA376E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    menthol (UNII: L7T10EIP3A)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-548-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/20/2021
    Labeler - CVS Pharmacy, Inc (062312574)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(69842-548)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(69842-548)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!