LISTERINE NIGHTLY RESET ANTICAVITY FLUORIDE TWILIGHT 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 ® Nightly Reset™ Anticavity Fluoride Mouthwash Twilight Mint™

Drug Facts

Active ingredients

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

Purpose

Anticavity

Uses

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 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

  • store at room temperature
  • cold weather may temporarily cloud this product

Inactive ingredients

water, sorbitol, propylene glycol, xylitol, poloxamer 407, sodium lauryl sulfate, sodium benzoate, phosphoric acid, eucalyptol, flavor, methyl salicylate, thymol, sodium saccharin, menthol, sucralose, disodium phosphate, red 40, blue 1

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 - 800 mL Bottle Label

ANTICAVITY FLUORIDE MOUTHWASH

Sodium Fluoride & Acidulated Phosphate Topical Solution

LISTERINE ®

NEW!

NIGHTLY
RESET™

WORKS HARD
TO HELP ERASE
THE EFFECTS
OF THE DAY

USE BEFORE AND AFTER SLEEP TO:
CLEAN DEEPLY
REPLENISH ENAMEL
DEFEND AGAINST CAVITIES

TWILIGHT MINT™
LESS INTENSE

IMPORTANT:
READ DIRECTIONS
FOR PROPER USE.

800 mL(1.7 pt)

PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label
LISTERINE NIGHTLY RESET ANTICAVITY FLUORIDE TWILIGHT MINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0478
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)  
XYLITOL (UNII: VCQ006KQ1E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
EUCALYPTOL (UNII: RV6J6604TK)  
THYMOL (UNII: 3J50XA376E)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0478-8800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201810/07/2021
2NDC:69968-0478-4400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201805/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/201810/07/2021
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 3/2023
Document Id: f6c2a1a0-6f42-298f-e053-6294a90adaa2
Set id: 786e9ba5-d0b0-4e22-a844-b90acbb69c18
Version: 4
Effective Time: 20230313
 
Johnson & Johnson Consumer Inc.