Label: LISTERINE HEALTHY WHITE RESTORING ANTICAVITY FLUORIDE CLEAN MINT- sodium fluoride mouthwash

  • NDC Code(s): 69968-0500-1, 69968-0500-2
  • Packager: Johnson & Johnson Consumer Inc.
  • 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 May 13, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

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

  • Purpose

    Anticavity

  • Use

    aids in prevention of dental cavities

  • Warnings

    Stop use and ask dentist if oral irritation or tooth sensitivity occurs

    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 12 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
    • supervise children as necessary until capable of using without supervision
    • Children under 12 years of age: consult a dentist or doctor
  • Other information

    • Protect from excessive heat (40°C/104°F)
  • Inactive ingredients

    Water, alcohol (10.5% v/v), sorbitol, hydrogen peroxide, PEG-40 hydrogenated castor oil, poloxamer 407, sodium saccharin, menthol, flavor, phosphoric acid, disodium phosphate, sucralose

  • Questions?

    call toll-free 888-222-0182 or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Distributed by: JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

    ANTICAVITY FLUORIDE MOUTHWASH
    LISTERINE®
    HEALTHY WHITE®
    RESTORING

    SODIUM FLUORIDE &
    ACIDULATED PHOSPHATE TOPICAL SOLUTION
    IMPORTANT: READ DIRECTIONS FOR PROPER USE
    FOR A HEALTHIER
    MOUTH

    *vs brushing alone
    in a lab study
    CLEAN MINT
    946mL (32 Fl Oz)

    PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE HEALTHY WHITE RESTORING ANTICAVITY FLUORIDE CLEAN MINT 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0500
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Sorbitol (UNII: 506T60A25R)  
    Hydrogen Peroxide (UNII: BBX060AN9V)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Phosphoric Acid (UNII: E4GA8884NN)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0500-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2010
    2NDC:69968-0500-2946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35501/01/2010
    Labeler - Johnson & Johnson Consumer Inc. (002347102)