Kids Anticavity

Manufacturer
Vi Jon, LLC
Effective date
2023-01-16
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
legacy-cache
Hydrated at
2026-08-01 21:39:56

Label at a glance#

ProductKids Anticavity
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

•adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste. •remove cap •pour 10 milliliters (10 mL mark on inside of cap):do not fill above the 10 mL mark •vigorously swish 10 milliliters 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 go...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity rinse

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 accidentaly swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

•adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.

•remove cap

•pour 10 milliliters (10 mL mark on inside of cap):do not fill above the 10 mL mark

•vigorously swish 10 milliliters 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

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse.

Distributed by: Vi-Jon, LLC  One Swan Drive, Smyrna, TN 37167

004.002/004AE

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sealed With Printed Neckband For Your Protection

SWAN

kids

ANTICAVITY

ALCOHOL FREE

FLUORIDE RINSE

bubble gum

FLAVOR

Strong Cavity Protection

Compare to the active ingredient of Bubblegum Blowout Act Anticavity Fluoride Rinse*

IMPORTANT:READ DIRECTIONS FOR PROPER USE

18 FL OZ (532 mL)

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0869-0004-442020-05-21C16284748780-19d75b9d0-2a4c-f424-e053-dadaa90a57ceAnticavity Fluoride Rinse 004 004.002/004AE
0869-0004-442020-01-31C16284748780-19d75b9d0-2a4c-f424-e053-dadaa90a57ceAnticavity Fluoride Rinse 004 004.002/004AE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1

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
0869-00040869-0004-44

Ingredients#

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

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

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
128c3cf7-b6a6-25ba-e063-6294a90a6f7836b98565-484f-4864-aebb-c488abab88e52024-02-29WarningsExact identifier
spl set id: 36b98565-484f-4864-aebb-c488abab88e5

Reported adverse events (FAERS/openFDA)#

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