Listerine Smart Rinse Anticavity Fluoride Rinse

Drug Labeling and Warnings

Drug Details [pdf]

LISTERINE  SMART RINSE PHINEAS AND FERB BUBBLE BLAST- 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 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, FD&C blue no. 1, FD&C green no. 3

Questions?

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

Disney
Phineas
And
Ferb

Helps Prevent Cavities
Removes Particles
Brushing May Miss

IMPORTANT: Read
directions for proper use.

ADA
Accepted
American
Dental
Association®

BUBBLE
BLAST

500 mL (16.9 fl oz)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
LISTERINE   SMART RINSE PHINEAS AND FERB BUBBLE BLAST
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42002-419
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.221 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Phosphoric Acid (UNII: E4GA8884NN)  
Sucralose (UNII: 96K6UQ3ZD4)  
Cetylpyridinium Chloride (UNII: D9OM4SK49P)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
FD&C Green No. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42002-419-72500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/25/201205/03/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/01/201105/03/2015
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2019
Document Id: baff2ff3-bf21-4dae-8edc-a14c55a81259
Set id: e19fd5cf-6de9-41f8-88ef-f52e2defb4a5
Version: 3
Effective Time: 20190925