Listerine Whitening Anticavity Mouthwash Vibrant Clean Mint

Drug Labeling and Warnings

Drug Details [pdf]

LISTERINE WHITENING ANTICAVITY VIBRANT - 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 Whitening Anticavity Mouthwash Vibrant
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 of age: consult a dentist or doctor

Other information

  • Store at Room Temperature.

Inactive ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

LISTERINE®
WHITENING®

anticavity mouthwash

VIBRANT

  • Removes Tough Surface Stains
  • Starts to Work on Contact
  • Whitens Teeth Safely
  • Kills Bad Breath Germs & Strengthens Teeth

CLEAN MINT

946 mL (32 Fl OZ)

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

Principal Display Panel - 946 mL Bottle Label
LISTERINE WHITENING ANTICAVITY VIBRANT - CLEAN MINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42002-509
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)  
Hydrogen Peroxide (UNII: BBX060AN9V)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sucralose (UNII: 96K6UQ3ZD4)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
Phosphoric Acid (UNII: E4GA8884NN)  
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42002-509-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/201309/07/2015
2NDC: 42002-509-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/201312/29/2015
3NDC: 42002-509-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/201312/29/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/15/201312/29/2015
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2019
Document Id: afbbf820-86e4-498a-bf69-198064500cf7
Set id: 39045c47-45f0-4554-a861-84f9d68b4454
Version: 2
Effective Time: 20190926
 
Johnson & Johnson Consumer Inc.