Label: LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - PINK LEMONADE FLAVOR- sodium fluoride mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2024

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  • 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

    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 6 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
      • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
      • Supervise children as necessary until capable of using without supervision
    • Children under 6 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, Flavor, Phosphoric Acid, Cetylpyridinium Chloride, Sucralose, Sodium Saccharin, Disodium Phosphate, Red 40, Red 33

  • 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 - 500 mL Bottle Label

    2X STRONGER TEETH FOR

    BETTER CAVITY PROTECTION*

    *with a brushing, in a lab study

    ALCOHOL FREE

    ANTICAVITY FLUORIDE RINSE

    LISTERINE ®

    SMART RiNSE ®

    SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

    PINK

    LEMONADE

    FLAVOR

    500 mL (16.9Fl Oz)

    IMPORTANT: Read

    directions for proper use.

    Pink Lemonade

  • INGREDIENTS AND APPEARANCE
    LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - PINK LEMONADE FLAVOR 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0691
    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)  
    SORBITOL (UNII: 506T60A25R)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0691-5500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/2021
    Labeler - Kenvue Brands LLC (118772437)
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