Label: LISTERINE HEALTHYWHITE RESTORING CLEAN MINT- sodium fluoride mouthwash

  • NDC Code(s): 42002-512-16, 42002-512-32
  • 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 September 11, 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 the prevention of dental cavities

  • Warnings

    Stop use and ask a 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 daily after brushing your teeth with a toothpaste
    • vigorously swish 10 mL (2 teaspoonfulls) 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 if age: consult a dentist of doctor
  • Other information

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

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

  • Questions?

    call toll-free 888-222-5545 or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Johnson & Johnson Healthcare Products
    Division of McNEIL-PPC, Inc.
    Skillman, NJ 08558-9418 USA

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    LISTERINE®

    HealthyWhite™

    anticavity fluoride mouthwash
    SODIUM FLOURIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
    RESTORING

    • 2X Stronger Enamel*
      & Whiter Teeth
    • Kills Bad Breath Germs

      CLEAN MINT

    473 mL (16 Fl Oz)

    IMPORTANT: READ DIRECTIONS FOR PROPER USE.
    DO NOT USE IF PRINTED LISTERINE® BAND AROUND CAP IS BROKEN OR MISSING.

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE HEALTHYWHITE RESTORING CLEAN MINT 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-512
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.1 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)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42002-512-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201005/13/2021
    2NDC:42002-512-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201010/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35501/01/201005/13/2021
    Labeler - Johnson & Johnson Consumer Inc. (002347102)