Label: LISTERINE HEALTHYWHITE VIBRANT CLEAN MINT- sodium fluoride mouthwash

  • NDC Code(s): 69968-0497-1, 69968-0497-2
  • 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 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 or doctor
  • Other information

    • store at room temperature
  • Inactive ingredients

    water, alcohol (8% v/v), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

  • 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®
    VIBRANT

    SODIUM FLUORIDE &
    ACIDULATED PHOSPHATE TOPICAL SOLUTION
    IMPORTANT: READ DIRECTIONS FOR PROPER USE
    FOR A WHITER
    SMILE IN 5 DAYS

    Individual results
    may vary
    CLEAN MINT
    946mL (32 Fl Oz)

    PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE HEALTHYWHITE VIBRANT CLEAN MINT 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0497
    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)  
    hydrogen peroxide (UNII: BBX060AN9V)  
    poloxamer 407 (UNII: TUF2IVW3M2)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sucralose (UNII: 96K6UQ3ZD4)  
    menthol, unspecified form (UNII: L7T10EIP3A)  
    phosphoric acid (UNII: E4GA8884NN)  
    sodium phosphate, dibasic, anhydrous (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0497-2473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2013
    2NDC:69968-0497-1946 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/2013
    Labeler - Johnson & Johnson Consumer Inc. (002347102)