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Listerine Whitening Restoring

Dosage form: rinse
Ingredients: Sodium Fluoride 0.2mg in 1mL
Labeler: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.
NDC Code: 42002-420

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

LISTERINE WHITENING RESTORING 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-420
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Alcohol 
Sorbitol 
Hydrogen Peroxide 
Polyoxyl 40 Hydrogenated Castor Oil 
Poloxamer 407 
Saccharin Sodium Dihydrate 
Phosphoric Acid 
Sodium Phosphate, Dibasic, Anhydrous 
Sucralose 
Packaging
#Item CodePackage Description
1NDC:42002-420-16473 mL in 1 BOTTLE, PLASTIC
2NDC:42002-420-32946 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35505/01/2012
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 05/2012
Document Id: 78490ae7-f023-495a-8212-1d8e09b966d8
Set id: 05254945-302f-4d6a-a545-46748fd2bb49
Version: 1
Effective Time: 20120502
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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