Label: FAMILY WELLNESS ANTICAVITY FRESH MINT- sodium fluoride mouthwash

  • Category: HUMAN OTC DRUG LABEL

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 August 23, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    Sodium fluoride 0.0221%

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Useaids in the prevention of dental cavities

  • WARNINGS

    Warnings

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older: use twice daily after brushing your teeth with toothpaste; vigorously swish 10 mL (2 teaspoonfuls) between teeth for 1 minute then spit out; do not swallow
    • children under 12 years of age: consult a dentist or doctor
  • STORAGE AND HANDLING

    Other information cold weather may cloud this product. Its antiseptic properties are not affected . Store at room temperature (59° - 77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients water, sorbitol, alcohol 21.6%, flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose and/or sodium saccharin, dibasic sodium phosphate, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Midwood Brands, LLC

    500 Volvo Parkway, Chesapeake, VA 23320

    Made in Canada

    * This product is not manufactured or distributed by Johnson & Johnson, distributor of Listerine®.

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO LISTERINE® TOTAL CARE*

    FAMILY wellness™

    TOTAL HEALTH

    FRESH MINT

    MOUTHWASH

    6 IN 1 FORMULA

    • Helps Prevent Cavities
    • Kills Germs that Cause Bad Breath
    • Helps Keep Mouth Feeling Clean
    • Freshens Breath
    • Helps Strengthen Enamel
    • Helps Strengthen Teeth

    33.8 FL OZ (1000 mL)

    Fresh Mint Mouthwash

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS  ANTICAVITY FRESH MINT
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-233
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SORBITOL (UNII: 506T60A25R)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-233-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/20/2019
    Labeler - Family Dollar Services Inc. (024472631)
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

More Info on this Drug

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