Label: ANTICAVITY RINSE- sodium fluoride mouthwash

  • NDC Code(s): 41250-004-44
  • Packager: Meijer Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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

View All Sections
  • Tamper Evident Statement

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Active ingredient

    Sodium fluoride 0.05% (0.02% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • Warnings

    for this product

  • Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, seep professional assistance or contact a Poison Control Center immediately.

  • Directions

    Adults and children 6 years 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 years of age: consult a dentist or doctor

  • Other information

    • store at room temperature
  • Inactive ingredients

    benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

  • Questions?

    1-888-593-0593

  • Disclaimer

    *This product is not manufactured or distributed by Chattem, Inc., distributor of Act® Bubblegum Blowout® Anticavity Kids Fluoride Rinse.

  • Adverse reactions

    Distributed BY

    Meijer Distribution, Inc.

    Grand Rapids, MI 49544

    www.meijer.com

    Our Quality Guarantee 

    www.meijer.com/satisfcation

    how2recycle.info

  • Principal Panel Display

    NDC 41250-004-44

    meijer®

    Kids Anticavity Fluoride Rinse

    Compare to ACT® ACTIVE INGREDIENT*

    ALCOHOL FREE

    BUBBLEGUM FLAVOR

    Helps prevent cavities

    Helps strengthen teeth

    Sugar free

    Fresh & clean

    ADA Accepted

    American Dental Association

    Helps prevent cavities

    IMPORTANT: read directions for proper use

    18 FL OZ (1.12 PT) 532 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MEPREDNISONE DISODIUM PHOSPHATE (UNII: W80C977F6O)  
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-004-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/27/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02106/27/2002
    Labeler - Meijer Distribution, Inc. (006959555)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(41250-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(41250-004)
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!