LISTERINE SMART ANTICAVITY - FROZEN  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
Frozen - Bubble Blast

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 day after brushing your teeth with a toothpaste
    • Remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of 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 solution, flavor, phosphoric acid, sucralose, cetylpyridinium chloride, disodium phosphate, sodium saccharin, blue 1, green 3

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®

SMART RINSE®

ANTICAVITY
FLUORIDE RINSE

Disney
FROZEN

Helps Prevent Cavities

Removes Particles
Brushing May Miss

BUBBLE BLAST

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 ANTICAVITY - FROZEN   BUBBLE BLAST
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-619
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
sorbitol (UNII: 506T60A25R)  
phosphoric acid (UNII: E4GA8884NN)  
sucralose (UNII: 96K6UQ3ZD4)  
cetylpyridinium chloride (UNII: D9OM4SK49P)  
sodium phosphate, dibasic, anhydrous (UNII: 22ADO53M6F)  
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:42002-619-72500 mL in 1 BOTTLE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug10/07/201406/13/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35510/07/201406/13/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 6/2016
Document Id: a36cd71f-84bf-47f9-b1ed-2830f724d03d
Set id: 7d29cbaa-0431-450c-a532-6f7c3c971f45
Version: 3
Effective Time: 20160616
 
Johnson & Johnson Consumer Inc.