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

  • NDC Code(s): 42002-516-16, 42002-516-32
  • 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 April 30, 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 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 if age: consult a dentist of doctor
  • Other information

    • Store at room temperature
  • Inactive ingredients

    water, alcohol (14%), sorbitol, tetrapotassium pyrophosphate, pentasodium triphosphate, poloxamer 407, citric acid, sodium benzoate, flavor, eucalyptol, thymol, sodium saccharin, menthol, sucralose

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Dist. Johnson & Johnson Healthcare Products
    Division of McNEIL-PPC, Inc.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    LISTERINE®

    Healthy White™
    anticavity fluoride mouthwash
    SODIUM FLUORIDE ORAL SOLUTION

    GENTLE

    • Removes & Prevents
      Tough Stains
    • Gentle on Enamel
    • Kills Bad Breath Germs

    CLEAN MINT

    473 mL (16 Fl Oz)

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

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE HEALTHY WHITE ANTICAVITY FLUORIDE GENTLE CLEAN MINT 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-516
    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)  
    Potassium Pyrophosphate (UNII: B9W4019H5G)  
    Sodium Tripolyphosphate Anhydrous (UNII: 9SW4PFD2FZ)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Eucalyptol (UNII: RV6J6604TK)  
    Thymol (UNII: 3J50XA376E)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42002-516-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/201403/10/2021
    2NDC:42002-516-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/201412/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35506/24/201403/10/2021
    Labeler - Johnson & Johnson Consumer Inc. (002347102)