Label: LISTERINE NIGHTLY RESET ANTICAVITY FLUORIDE TWILIGHT MINT- sodium fluoride mouthwash

  • NDC Code(s): 69968-0478-4, 69968-0478-8
  • 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 14, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

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

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental cavities

  • 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.

  • 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

    • store at room temperature
    • cold weather may temporarily cloud this product
  • Inactive ingredients

    water, sorbitol, propylene glycol, xylitol, poloxamer 407, sodium lauryl sulfate, sodium benzoate, phosphoric acid, eucalyptol, flavor, methyl salicylate, thymol, sodium saccharin, menthol, sucralose, disodium phosphate, red 40, blue 1

  • Questions?

    call toll-free 888-222-0182 or 215-273-8755 (collect). www.listerine.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label

    ANTICAVITY FLUORIDE MOUTHWASH

    Sodium Fluoride & Acidulated Phosphate Topical Solution

    LISTERINE®

    NEW!

    NIGHTLY
    RESET™

    WORKS HARD
    TO HELP ERASE
    THE EFFECTS
    OF THE DAY

    USE BEFORE AND AFTER SLEEP TO:
    CLEAN DEEPLY
    REPLENISH ENAMEL
    DEFEND AGAINST CAVITIES

    TWILIGHT MINT™
    LESS INTENSE

    IMPORTANT:
    READ DIRECTIONS
    FOR PROPER USE.

    800 mL(1.7 pt)

    PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE NIGHTLY RESET ANTICAVITY FLUORIDE TWILIGHT MINT 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0478
    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)  
    Sorbitol (UNII: 506T60A25R)  
    xylitol (UNII: VCQ006KQ1E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Phosphoric Acid (UNII: E4GA8884NN)  
    Eucalyptol (UNII: RV6J6604TK)  
    Thymol (UNII: 3J50XA376E)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0478-8800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
    2NDC:69968-0478-4400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35506/01/2018
    Labeler - Johnson & Johnson Consumer Inc. (002347102)