Anticavity Rinse Fluoride Rinse

Manufacturer
American Sales Company | Vi Jon
Effective date
2010-05-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:53:10

Label at a glance#

ProductAnticavity Rinse Fluoride Rinse
Active ingredientSodium Fluoride
Label structure7 sections

Storage and handling

Other information store at 20⁰ to 25⁰ C (68⁰ to 77⁰ F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

 Active ingrident                                          Purpose                                      

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

INDICATIONS & USAGE SECTION

Use aids in the prevention of dental cavities

WARNINGS SECTION

Warnings
Keep out of reach of children
.  If more than used for rinsing is accidentally swallowed, see professional assistance or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

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

•remove cap

•pour 10 milliliters (10 mL mare on inside of cap); do not fill above 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.

STORAGE AND HANDLING SECTION

Other information store at 20⁰ to 25⁰ C (68⁰ to 77⁰ F)

INACTIVE INGREDIENT SECTION


Inactive ingredients water, sorbitol solution, propylene glycol, flavors, phosphoric acid, sucralose, cetylpridinium chloride, disodium phosphate, methylparaben, propylparaben, yellow 6, blue1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For Kids Anticavity

Fluoride Rinse

Mint Flavor 

Sealed With Printed Neckband For Your Protection

•Kill germs that cause bad breath

•Helps Prevent cavities

•Alcohol Free

16.9 FL OZ (500 mL)

IMPORTANT: Read directions for proper use.

image of product labelimage of product label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041520885029GTIN-13: 0041520885029
EAN-13: 0041520885029
GTIN-12: 041520885029
UPC-A: 041520885029
GTIN storage (14 digits): 00041520885029
mm4.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-344-772020-03-09C16284748780-19d75b9d0-a909-f424-e053-dadaa90a57ceDrug Facts
41520-344-772020-01-31C16284748780-19d75b9d0-a909-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W72
FLUORIDE IONACTIVE MOIETYQ80VPU408O2

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-34441520-344-77

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIB

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
4fb0e6ca-458c-453d-9238-0dd1bd0f0d0739d5f994-070f-4099-84e5-d8b673b4af272020-03-09Warnings, Adverse reactionsExact identifier
spl set id: 39d5f994-070f-4099-84e5-d8b673b4af27

Reported adverse events (FAERS/openFDA)#

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