Label: ALCOHOL FREE REFRESHING MINT- 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 April 20, 2022

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

View All Sections
  • TEP

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • claims

    H-E-B

    Refreshing Mint

    ALCOHOL

    FREE

  • Active ingredient

    Sodium fluoride 0.02% (0.01% 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, get medical help or contact a Poison Control Center right away

  • Directions

    Adults and children 6 years of age and oler:

    • use twice a day after brushing your teeth with 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
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessare until capable of using without supervision
    • children under 6 years of age: consult a dentist or doctor
  • Inactive ingredients

    water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

  • Questions

    Call 1-888-593-0593

  • Claims

    This rinse may cause temporary staining to the surface of teeth.  This is not harmful, and adequate brushing may prevent its occurrence.

  • Adverse Reactions

    MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204

  • disclaimer

    This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Anticavity Fluoride Mouthwash

  • principal display panel

    Compare to Crest

    Pro-Health Anticavity

    Fluoride MouthWash

    H-E-B

    Refreshing Mint

    ALCOHOL

    FREE

    ANTICAVITY MOUTH RINSE

    WITH FLUORIDE

    • Helps prevent cavities
    • Helps fight germs that cause bad breath
    • Freshens breath with no alcohol burn

    IMPORTANT: read directions for proper use.

    33.8 FL OZ (1 QT) 1L

    image description

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE REFRESHING MINT 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-576
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION10.41 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-576-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/27/2015
    Labeler - HEB (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-576)
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!