Alcohol-Free Anticavity

Manufacturer
American Sales Company | Vi-Jon
Effective date
2020-05-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 23:32:11

Label at a glance#

ProductAlcohol-Free Anticavity
Active ingredientSODIUM FLUORIDE
Label structure12 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 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 ...

Label contents#

Full prescribing information#

TEP

OTHER SAFETY INFORMATION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.0 1% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warning

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 daily 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, glycerin, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Claims

SPL UNCLASSIFIED SECTION

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.

Dislcaimer

SPL UNCLASSIFIED SECTION

Ths product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse.

482.001/482AB

Adverse reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY:

FODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredient in Crest Pro-Health Advanced Anticavity Fluoride Mouthwash

CAREONE

ALCOHOL FREE FLUORIDE

MOUTH

WASH

ANTICAVITY FLUORIDE RINSE

VIOLET MINT FLAVOR

Kils Bad Breath Germs

Helps Prevent Cavities

Helps Strengthen Enamel

Cleans Teeth

Freshens Breath

1 LITER

(3.8 FL OZ)

IMPORTANT: Read directions for proper use

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-482-862023-10-23C16284748780-1d6a99b39-7176-a426-e053-dadaa90af4c2Drug Facts
41520-482-862022-01-28C16284748780-1d6a99b39-7176-a426-e053-dadaa90af4c2Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-48241520-482-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
980c0ddb-d9a5-49c1-819b-7b1c4a5fc12ed4eb45a2-e65c-409e-8165-be6dee6c9ed02023-10-23Warnings, Adverse reactionsExact identifier
spl set id: d4eb45a2-e65c-409e-8165-be6dee6c9ed0

Reported adverse events (FAERS/openFDA)#

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