Listerine Smart Rinse Bubble Gum Shield

Drug Labeling and Warnings

Drug Details [pdf]

LISTERINE SMART RINSE  BUBBLE GUM SHIELD- 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
Bubble Gum Shield

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. Stop squeezing. Excess liquid will drain back into 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 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 toll-free 1-888-222-0182 or 215-273-8755 (collect)

Distributed by:
Johnson & Johnson Healthcare Products
Division of McNEIL-PPC, Inc.
Skillman, NJ 08558-9418 USA

PRINCIPAL DISPLAY PANEL - 95 mL Bottle Label

LISTERINE®
SMART
RINSE®
ANTICAVITY
FLUORIDE RINSE

BUBBLE
GUM
SHIELD™

ALCOHOL FREE
Helps Prevent Cavities
Strengthens Teeth
Removes Particles Brushing May Miss

Do not use if printed band around cap is broken or missing.

95 mL (3.2 fl oz)
IMPORTANT: Read directions for proper use.

PRINCIPAL DISPLAY PANEL - 95 mL Bottle Label
LISTERINE SMART RINSE   BUBBLE GUM SHIELD
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42002-506
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)  
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
D&C Red No. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42002-506-9595 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/201208/25/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/25/201208/25/2012
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 5/2019
Document Id: cc3d2d04-eb28-4205-90d2-7e7b1376c2d4
Set id: 283fea4d-a8e5-42fa-8617-da9235b8be85
Version: 2
Effective Time: 20190507