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Listerine SmartRinse Anticavity Fluoride Rinse Avengers

Dosage form: mouthwash
Ingredients: Sodium Fluoride 0.1mg in 1mL
Labeler: Johnson & Johnson Consumer Inc.
NDC Code: 42002-618

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® SMART RINSE® ANTICAVITY FLUORIDE RINSE
AVENGERS - MINT SHIELD

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

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 6 years of age and older:
    • use twice a daily after brushing your teeth with a toothpaste
    • remove cap and hold bottle upright. Fill to10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in a cup.
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • replace cap promptly after use
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision
  • Children under 6 years of age: consult a dentist or doctor

Other information
  • Store at Room Temperature
  • do not use if printed band around cap is broken or missing

Inactive ingredients

water, sorbitol, sucralose, phosphoric acid, cetylpyridinium chloride, menthol, disodium phosphate, flavor, yellow 6, blue 1

Questions?

call toll-free 888-222-0182 or 215-273-8755 (collect)

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®
SMART RINSE®
ANTICAVITY
FLUORIDE RINSE

MARVEL
AVENGERS

Helps Prevent Cavities
Removes Particles
Brushing May Miss

IMPORTANT; Read
Directions for proper use.

ADA
Accepted
American
Dental Association®

MINT
SHIELD®

500 mL (16.9 fl oz)

LISTERINE SMARTRINSE ANTICAVITY FLUORIDE RINSE   AVENGERS
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-618
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
Sucralose 
Phosphoric Acid 
Cetylpyridinium Chloride 
Sodium Phosphate, Dibasic, Anhydrous 
FD&C Yellow No. 6 
FD&C Blue No. 1 
Packaging
#Item CodePackage Description
1NDC:42002-618-72500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35505/12/2014
Labeler - Johnson & Johnson Consumer Inc. (002347102)

 
Johnson & Johnson Consumer Inc.

Medically reviewed on Oct 29, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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