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

  • NDC Code(s): 69968-0691-5
  • 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 January 11, 2023

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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.

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
  • 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 finalpart35501/01/2021
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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