FDA.reportPublic FDA data

LISTERINE NATURALS Enamel Repair Anticavity Fluoride, Herbal Mint

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-03-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:33:36

Label at a glance#

ProductLISTERINE NATURALS Enamel Repair Anticavity Fluoride, Herbal Mint
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

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

Storage and handling

Store at room temperature Cold weather may temporarily cloud this product

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.02% (0.01% w/v Fluoride Ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • Store at room temperature
  • Cold weather may temporarily cloud this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-069769968-0697-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
EUCALYPTOLRV6J6604TKIACT
METHYL SALICYLATELAV5U5022YIACT
THYMOL3J50XA376EIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
PHOSPHORIC ACIDE4GA8884NNIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f82ca7e6-309b-6166-e053-6394a90a53754a5b5cf5-e944-451e-8069-e2385e796b352023-03-31WarningsExact identifier
spl id: f82ca7e6-309b-6166-e053-6394a90a5375
spl set id: 4a5b5cf5-e944-451e-8069-e2385e796b35

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.