LISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE AVENGERS- 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.

----------

LISTERINE ® SmartRinse ® Avengers – Mint Shield Anticavity Fluoride Rinse

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
  • remove cap and hold bottle upright. Fill to 10mL 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 a 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, sucralose, phosphoric acid, cetylpyridinium chloride, menthol, disodium phosphate, flavor, yellow 6, blue 1

Questions?

call toll-free 888-222-0182 or 215-273-8755 (collect)

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

2X STRONGER TEETH
FOR BETTER CAVITY PROTECTION*

ANTICAVITY FLUORIDE RINSE

LISTERINE ®

SMART RiNSE ®

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

ALCOHOL FREE

MARVEL
AVENGERS

*Versus brushing alone,
In a lab study.

IMPORTANT: Read
directions for proper use.

ADA
Accepted
American
Dental
Association ®

MINT
SHIELD

500 mL (16.9 fl oz)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
LISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE  AVENGERS
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0659
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
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0659-5500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/201909/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/08/201909/15/2022
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2022
Document Id: ebd6215a-ff20-7764-e053-2995a90af01a
Set id: a9b5223e-b19a-4265-a359-447ab29a16d5
Version: 3
Effective Time: 20221025
 
Johnson & Johnson Consumer Inc.