LISTERINE FLUORIDE DEFENSE ANTICAVITY MINT 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® Fluoride Defense Anticavity Mouthwash

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 12 years of age and older:
    • use twice daily after brushing your teeth with a toothpaste
    • 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
    • supervise children as necessary until capable of using without supervision
  • Children under 12 years of age: consult a dentist or doctor

Other information

  • store at controlled room temperature 20° - 25°C (68° - 77°F)
  • cold weather may temporarily cloud this product

Inactive ingredients

water, sorbitol solution, alcohol (21.6%), poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disodium phosphate, FD&C blue no. 1

Questions?

Call toll-free 1-888-222-0182 or 215-273-8755 (collect)

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

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

LISTERINE®
FLUORIDE
DEFENSE™
ANTICAVITY MOUTHWASH

SODIUM FLUORIDE & ACIDULATD PHOSPHATE TOPICAL SOLUTION
Shields Teeth from
Cavity Causing Acids,
Rebuilds Minerals &
Strengthens Enamel

IMPORTANT: Read directions
for proper use.
Replaces LISTERINE® Restoring

FROM THE #1 DENTIST RECOMMENDED BRAND*
#1

MINT SHIELD®

Principal Display Panel - 1.0 L Bottle Label
LISTERINE FLUORIDE DEFENSE ANTICAVITY MINT SHIELD 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-450
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)  
Alcohol (UNII: 3K9958V90M)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Eucalyptol (UNII: RV6J6604TK)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Thymol (UNII: 3J50XA376E)  
Phosphoric Acid (UNII: E4GA8884NN)  
Sucralose (UNII: 96K6UQ3ZD4)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-450-711000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/201107/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/201107/15/2021
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2020
Document Id: 29ca0cf1-8803-4f4d-b773-a4635bd36e24
Set id: 8dba8f97-c415-4f40-bdd8-f7d253ea57c7
Version: 3
Effective Time: 20200430
 
Johnson & Johnson Consumer Inc.