Medication Guide App

Listerine Smart Rinse Barbie

Dosage form: mouthwash
Ingredients: Sodium Fluoride 0.221g in 1mL
Labeler: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.
NDC Code: 42002-418

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

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

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 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 out.
    • 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
    • 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 controlled room temperature 20° - 25°C (68° - 77°F)
  • do not use if printed band around cap is broken or missing

Inactive ingredients

water, sorbitol solution, flavor, phosphoric acid, sucralose, cetylpyridinium chloride, disodium phosphate, sodium saccharin, D&C red no. 33

Questions?

call call toll-free 1-888-222-0182 or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®
SMART RINSE®
ANTICAVITY
FLUORIDE RINSE

Barbie

Helps Prevent Cavities
Removes Particles
Brushing May Miss

IMORTANT: Read
Directions for proper use.

ADA
Accepted

American
Dental
Association®

Fab
Bubble Gum™

500 mL (16.9 fl oz)

LISTERINE   SMART RINSE BARBIE
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-418
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride0.221 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
Phosphoric Acid 
Sucralose 
Cetylpyridinium Chloride 
Saccharin Sodium Dihydrate 
D&C Red No. 33 
Packaging
#Item CodePackage Description
1NDC:42002-418-72500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/01/2011
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 07/2012
 
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)