LISTERINE SMART RINSE BERRY SPLASH- sodium fluoride mouthwash 
Johnson & Johnson Consumer Inc.

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.

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LISTERINE ® SMART RiNSE ® BERRY SPLASH

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

Other information

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

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
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)

Revised: 1/2023
Document Id: eed330b1-f9d1-6768-e053-2995a90a17bb
Set id: 5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b
Version: 5
Effective Time: 20230105
 
Johnson & Johnson Consumer Inc.