LISTERINE WHITENING®RESTORING Fluoride Rinse

Drug Labeling and Warnings

Drug Details [pdf]

LISTERINE WHITENING RESTORING- sodium fluoride rinse 
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 WHITENING®
RESTORING Fluoride Rinse

Drug Facts

Active ingredient

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Stop use and ask a 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 daily 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 controlled room temperature 20° - 25°C (68° - 77°F)

Inactive ingredients

water, alcohol (10.5%), sorbitol solution, hydrogen peroxide, PEG-40 hydrogenated castor oil, flavors, poloxamer 407, sodium saccharin, phosphoric acid, disodium phosphate, sucralose

Questions?

call 1-888-222-5545, weekdays

Dist: Johnson & Johnson Healthcare Products
Division of McNEIL-PPC, Inc.
Skillman, NJ 08558-9418 USA

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

LISTERINE®
WHITENING
fluoride whitening rinse

RESTORING

  • Whitens Teeth Safely
  • Restores Enamel to
    Strengthen Teeth
  • Helps Prevent Tooth Decay
  • Kills Bad Breath Germs

CLEAN MINT

473 mL (16 Fl Oz)

IMPORTANT: READ DIRECTION FOR PROPER USE.
DO NOT USE IF PRINTED LISTERINE® BAND AROUND CAP IS BROKEN OR MISSING

Principal Display Panel
LISTERINE WHITENING RESTORING 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42002-420
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.2 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)  
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
Sucralose (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42002-420-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/201211/06/2015
2NDC: 42002-420-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/201209/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35505/01/201209/11/2017
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2019
Document Id: 290db60b-e4c2-4fbc-bd43-37ab75b50de0
Set id: 05254945-302f-4d6a-a545-46748fd2bb49
Version: 2
Effective Time: 20190926