LISTERINE ® NATURALS ENAMEL REPAIR ANTICAVITY FLUORIDE MOUTHWASH HERBAL MINT

LISTERINE NATURALS Enamel Repair Anticavity Fluoride, Herbal Mint by

Drug Labeling and Warnings

LISTERINE NATURALS Enamel Repair Anticavity Fluoride, Herbal Mint by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LISTERINE NATURALS ENAMEL REPAIR ANTICAVITY FLUORIDE, HERBAL MINT- 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 ® NATURALS ENAMEL REPAIR ANTICAVITY FLUORIDE MOUTHWASH HERBAL MINT

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, Alcohol (21.6% v/v), Sorbitol, Poloxamer 407, Eucalyptol, Methyl Salicylate, Thymol, Stevia Rebaudiana Leaf Extract, Phosphoric Acid, Menthol, Flavor, Disodium Phosphate

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

LISTERINE ®

NATURALS

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

ANTICAVITY FLUORIDE MOUTHWASH

ENAMEL REPAIR

HELPS RESTORE ENAMEL & KILLS
99.9% OF BAD BREATH GERMS

HERBAL MINT

500mL (1.05 Pt)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
LISTERINE NATURALS ENAMEL REPAIR ANTICAVITY FLUORIDE, HERBAL MINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69968-0697
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)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
THYMOL (UNII: 3J50XA376E)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69968-0697-5500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/202110/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/04/202110/02/2023
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 3/2023
Document Id: f82ca7e6-309b-6166-e053-6394a90a5375
Set id: 4a5b5cf5-e944-451e-8069-e2385e796b35
Version: 4
Effective Time: 20230331