LISTERINE® HealthyWhite™ anticavity fluoride mouthwash RESTORING CLEAN MINT

LISTERINE® HealthyWhite™ anticavity fluoride mouthwash RESTORING CLEAN MINT

Drug Labeling and Warnings

Drug Details

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LISTERINE HEALTHYWHITE RESTORING 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® HealthyWhite™ anticavity fluoride mouthwash RESTORING CLEAN MINT

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

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 teaspoonfulls) 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 if age: consult a dentist of doctor

Other information

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

Inactive ingredients

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

Questions?

call toll-free 888-222-5545 or 215-273-8755 (collect)

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

LISTERINE®

HealthyWhite™

anticavity fluoride mouthwash
SODIUM FLOURIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
RESTORING

  • 2X Stronger Enamel*
    & Whiter Teeth
  • Kills Bad Breath Germs

    CLEAN MINT

473 mL (16 Fl Oz)

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

Principal Display Panel - 473 mL Bottle Label
LISTERINE HEALTHYWHITE RESTORING CLEAN MINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42002-512
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.1 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)  
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
Sucralose (UNII: 96K6UQ3ZD4)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42002-512-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 42002-512-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35509/03/2014
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2016
 
Johnson & Johnson Consumer Inc.


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