LISTERINE ® STRONG TEETH ANTICAVITY FLUORIDE MOUTHWASH MINT SHIELD ®

Listerine Strong Teeth Anticavity Fluoride Mint Shield by

Drug Labeling and Warnings

Listerine Strong Teeth Anticavity Fluoride Mint Shield by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LISTERINE STRONG TEETH ANTICAVITY FLUORIDE 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.

----------

LISTERINE ® STRONG TEETH ANTICAVITY FLUORIDE MOUTHWASH MINT 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 12 years of age and older:
  • Use twice a day 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 room temperature
  • Cold weather may temporarily cloud this product

Inactive ingredients

Water, Sorbitol, Alcohol (21.6% v/v), Poloxamer 407, Sodium Lauryl Sulfate, Eucalyptol, Flavor, Methyl Salicylate, Thymol, Phosphoric Acid, Sucralose, Menthol, Disodium Phosphate, Blue 1

Questions?

call toll-free 888-222-0182 or 215-273-8755 (collect). www.listerine.com

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ANTICAVITY FLUORIDE MOUTHWASH

LISTERINE ®

STRONG TEETH

IMPORTANT: READ DIRECTIONS FOR PROPER USE
SODIUM FLUORIDE &
ACIDULATED PHOSPAHTE TOPICAL SOLUTION

HELPS PROTECT & DEFEND
TEETH AGAINST CAVITIES

500mL (1.05 Pt)
MINT SHEILD ®

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
LISTERINE STRONG TEETH ANTICAVITY FLUORIDE MINT SHIELD 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69968-0696
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.1 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: 69968-0696-5500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/202104/13/2023
2NDC: 69968-0696-11000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/202104/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/04/202104/13/2023
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 3/2023
Document Id: f6c2ff8f-bf3d-6f6d-e053-6394a90a2529
Set id: bfde612d-4170-422f-ab61-ecb8104134c9
Version: 3
Effective Time: 20230313