LISTERINE SMART RINSE BARBIE - sodium fluoride mouthwash
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

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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 1-888-222-0182, weekdays

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

New
Flavor!
LISTERINE®

SMART
RiNSE®
ANTICAVITY
FLUORIDE RINSE

Barbie™

Helps Prevent Cavities
Removes Particles
Brushing May Miss

Fab
Bubble
Gum™

IMPORTANT: Read
directions for proper use.
500 mL (16.9 fl oz)

Principal Display Panel - 500 mL Bottle Label

LISTERINE SMART RINSE BARBIE
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	42002-418
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (Fluoride Ion)	Sodium Fluoride	0.221 g in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water
Sorbitol
Phosphoric Acid
Sucralose
Cetylpyridinium Chloride
Saccharin Sodium
D&C Red No. 33

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	42002-418-72	500 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	02/01/2011

Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 01/2011Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.