FDA.reportPublic FDA data

Anticavity

Manufacturer
Liberty Procurement, Inc | Consumer Product Partners, LLC
Effective date
2024-07-31
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 20:57:34

Label at a glance#

ProductAnticavity
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and Children 6 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 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 6 years of age: consult a dentist or doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 6 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 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 6 years of age: consult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash

Distributed by
Liberty Procurement Co. Inc.
Union, NJ 07083 USA
www.facevalues.com

SATISFACTION GUARANTEED Or Your Money Back

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COREVALUES

Compare to Listerine Total Care Fresh Mint*

Anticavity MOUTHWASH

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

MULTIPLE BENEFITS

IN ONE RINSE:

  • Helps prevent cavities
  • Restores enamel
  • Strengthens teeth
  • Kills germs that cause bad breath
  • Freshens breath
  • Leaves mouth feeling clean

IMPORTANT:

Read directions for proper use.

Mint Flavor

1 LITER (1 QT 1.8 fl oz)

Sealed With Printed Neckband For Your Protection

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-16363940-163-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
EUCALYPTOLRV6J6604TKIACT
METHYL SALICYLATELAV5U5022YIACT
MENTHOLL7T10EIP3AIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
THYMOL3J50XA376EIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
24b3f88f-4205-5e5c-e063-6394a90ab26aeb05dc38-b8c4-4cb3-a0fe-281cc9cdfe1c2024-10-17WarningsExact identifier
spl set id: eb05dc38-b8c4-4cb3-a0fe-281cc9cdfe1c

Reported adverse events (FAERS/openFDA)#

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