LISTERINE® HealthyWhite™ anticavity fluoride mouthwash GENTLE CLEAN MINT

LISTERINE® HealthyWhite™ anticavity fluoride mouthwash GENTLE CLEAN MINT

Drug Labeling and Warnings

Drug Details

k">

LISTERINE HEALTHY WHITE ANTICAVITY FLUORIDE GENTLE 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.

----------

LISTERINE® HealthyWhite™ anticavity fluoride mouthwash GENTLE 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 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 if age: consult a dentist of doctor

Other information

  • Store at room temperature

Inactive ingredients

water, alcohol (14%), sorbitol, tetrapotassium pyrophosphate, pentasodium triphosphate, poloxamer 407, citric acid, sodium benzoate, flavor, eucalyptol, thymol, sodium saccharin, menthol, sucralose

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

LISTERINE®

Healthy White™
anticavity fluoride mouthwash
SODIUM FLUORIDE ORAL SOLUTION

GENTLE

  • Removes & Prevents
    Tough Stains
  • Gentle on Enamel
  • Kills Bad Breath Germs

CLEAN MINT

473 mL (16 Fl Oz)

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
LISTERINE HEALTHY WHITE ANTICAVITY FLUORIDE GENTLE CLEAN MINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42002-516
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)  
Potassium Pyrophosphate (UNII: B9W4019H5G)  
Sodium Tripolyphosphate Anhydrous (UNII: 9SW4PFD2FZ)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Eucalyptol (UNII: RV6J6604TK)  
Thymol (UNII: 3J50XA376E)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sucralose (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42002-516-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 42002-516-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35506/24/2014
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2016
 
Johnson & Johnson Consumer Inc.


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.