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Listerine

Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

Listerine Smart Rinse Anticavity Fluoride Rinse


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Listerine 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

Listerine

Sodium Fluoride MOUTHWASH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42002-418
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.221 g

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
phosphoric acid
Sucralose
cetylpyridinium chloride
SACCHARIN SODIUM DIHYDRATE
D&C RED NO. 33

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42002-418-72 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-02-01


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