Anticavity

Manufacturer
American Sales Company | Vi-Jon, LLC
Effective date
2023-02-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:36:35

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 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 instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of u...

Label contents#

Full prescribing information#

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

For this product

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 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
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol, sorbitol, hydrogen peroxide, PEG-40 hydrigebated castor oil, poloxamer 407, sodium saccharin, menthol, flavor, phosphoric acid, disodium phosphate, sucralose

Other information

SPL UNCLASSIFIED SECTION

store at room temperature (59º-77ºF)

Questions?

OTC - QUESTIONS SECTION

Call 1-888-287-1915

SPL UNCLASSIFIED SECTION

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Healthy White Restoring Anticavity Mouthrinse

Distributed by Foodhold USA, LLC

Landover, MD 20785

For product questions or concerns, contact us at 1-877-846-9949

(c) 2018 Ahold Delhaize Licensing Sarl

Quality guaranteed or your money back

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Care One

Compare to the active ingredient in Listerine Healthy White Resotring Anticavity Mouthrinse*

Whiten & Restore Anticavity Mouthrinse

Stronger enamel & whiter teeth

Kills germs that cause bad breath

Minty Fresh

IMPORTANT: Read directions for proper use.

32 FL OZ (946 mL)

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-81241520-812-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
c15e58e3-8f06-413f-b9e9-fe8883fb5c4ee0aee8cb-9749-49c9-9ffb-3c79c21eb14a2023-10-20WarningsExact identifier
spl set id: e0aee8cb-9749-49c9-9ffb-3c79c21eb14a

Reported adverse events (FAERS/openFDA)#

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