FDA.reportPublic FDA data

Listerine Healthy White Restoring Anticavity Fluoride Clean Mint

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-03-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:35:25

Label at a glance#

ProductListerine Healthy White Restoring Anticavity Fluoride Clean 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

Protect from excessive heat (40°C/104°F)

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 prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use and ask dentist if oral irritation or tooth sensitivity occurs

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

  • Protect from excessive heat (40°C/104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, alcohol (10.5% v/v), sorbitol, hydrogen peroxide, PEG-40 hydrogenated castor oil, poloxamer 407, sodium saccharin, menthol, flavor, phosphoric acid, disodium phosphate, sucralose

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTICAVITY FLUORIDE MOUTHWASH
LISTERINE ®
HEALTHY WHITE ®
RESTORING
SODIUM FLUORIDE &
ACIDULATED PHOSPHATE TOPICAL SOLUTION
IMPORTANT: READ DIRECTIONS FOR PROPER USE
FOR A HEALTHIER
MOUTH
*vs brushing alone
in a lab study
CLEAN MINT
946mL (32 Fl Oz)

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 946 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
69968-050069968-0500-1, 69968-0500-2

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
HYDROGEN PEROXIDEBBX060AN9VIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
POLOXAMER 407TUF2IVW3M2IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

Source Document#

Source XML · Source PDF

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
f5d09709-7d94-f7fd-e053-2a95a90a792dcab31344-791a-4633-a279-423d647e4e672023-03-01WarningsExact identifier
spl id: f5d09709-7d94-f7fd-e053-2a95a90a792d
spl set id: cab31344-791a-4633-a279-423d647e4e67

Reported adverse events (FAERS/openFDA)#

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