Label: LISTERINE SMART RINSE BERRY SPLASH- sodium fluoride mouthwash

  • NDC Code(s): 69968-0606-3, 69968-0606-5
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL

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 5, 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 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
    • remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in the cup.
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • replace cap promptly after use
    • 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
  • Inactive ingredients

    water, sorbitol, flavor, phosphoric acid, cetylpyridinium chloride, sucralose, sodium saccharin, disodium phosphate, red 33, green 3

  • 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 - 500 mL Bottle Label

    NEW!
    2X STRONGER TEETH
    FOR BETTER CAVITY PROTECTION*
    ANTICAVITY FLUORIDE RINSE
    LISTERINE ®
    SMART RiNSE ®
    SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
    ALCOHOL FREE

    *Versus brushing alone,
    In a lab study.
    IMPORTANT: Read
    directions for proper use.

    ADA
    Accepted
    American
    Dental
    Association ®

    BERRY
    SLASH
    500 mL (16.9 fl oz)

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LISTERINE SMART RINSE BERRY SPLASH 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0606
    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)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0606-5500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/06/202009/08/2022
    2NDC:69968-0606-327 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/06/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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