LISTERINE HEALTHY WHITE RESTORING ANTICAVITY FLUORIDE CLEAN MINT- 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 ® HEALTHY WHITE ® RESTORING ANTICAVITY FLUORIDE MOUTHWASH CLEAN MINT

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in prevention of dental cavities

Warnings

Stop use and ask dentist if oral irritation or tooth sensitivity occurs

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 12 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
  • supervise children as necessary until capable of using without supervision
  • Children under 12 years of age: consult a dentist or doctor

Other information

  • Protect from excessive heat (40°C/104°F)

Inactive ingredients

Water, alcohol (10.5% v/v), sorbitol, hydrogen peroxide, PEG-40 hydrogenated castor oil, poloxamer 407, sodium saccharin, menthol, flavor, phosphoric acid, disodium phosphate, sucralose

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

ANTICAVITY FLUORIDE MOUTHWASH
LISTERINE ®
HEALTHY WHITE ®
RESTORING
SODIUM FLUORIDE &
ACIDULATED PHOSPHATE TOPICAL SOLUTION
IMPORTANT: READ DIRECTIONS FOR PROPER USE
FOR A HEALTHIER
MOUTH
*vs brushing alone
in a lab study
CLEAN MINT
946mL (32 Fl Oz)

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
LISTERINE HEALTHY WHITE RESTORING ANTICAVITY FLUORIDE CLEAN MINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0500
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)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0500-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201009/24/2023
2NDC:69968-0500-2946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201009/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/201009/24/2023
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 3/2023
Document Id: f5d09709-7d94-f7fd-e053-2a95a90a792d
Set id: cab31344-791a-4633-a279-423d647e4e67
Version: 4
Effective Time: 20230301
 
Johnson & Johnson Consumer Inc.