Label: ANTICAVITY- sodium fluoride mouthwash

  • 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 27, 2023

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

View All Sections
  • TEP

    Sealed With Printed Neckband For Your Protection

  • Active ingredient

    Sodium fluoride 0.02% (0.009% w/v fluoride ion)

  • Purpose

    anticavity

  • 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 a day 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

    water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate calcium disodium EDTA, blue 1

  • Questions

    Call 1-888-287-1915

  • Adverse reaction

    Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

    DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by chattem Inc., owner of the registered mark Act Restoring Anticavity Fluoride Mouthwash Cool Mint.

  • Principal panel display

    equate

    Compare to Act® Restoring™ Anticavity Fluoride Mouthwash Active Ingredient*

    Restoring Anticavity

    Fluoride

    Mouthwash

    • Restores enamel
    • Helps remineralize soft spots

    IMPORTANT: read directions for proper use.

    Refreshing Mint

    Made in the USA WITH 90% OR MORE US PARTS

    Factory Certified

    1 LITER (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-581
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-581-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/25/2016
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(49035-581)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(49035-581)
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!