ANTICAVITY FLUORIDE RINSE- anticavity fluoride mouthwash

Anticavity Fluoride Rinse by

Drug Labeling and Warnings

Anticavity Fluoride Rinse by is a Otc medication manufactured, distributed, or labeled by Vi Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                          Purpose

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

INDICATIONS & USAGE

Use aids in the prevention of dental cavities

WARNINGS

Warnings

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

DOSAGE & ADMINISTRATION

Directions

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

remove cap

pour 10 milliliters (10 mL mark on inside of cap); do not fill about 10 mL mark

vigorously swish 10 milliliter of rinse between your teeth for 1 minute and then spit out

do not sallow the rinse

do not eat or drink 30 minute 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

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

INACTIVE INGREDIENT

Inactive ingredients water, sorbitol solution, propylene glycol, flavors, phosphoric acid, sucralose, cetylpyridinium chloride, disodium phosphate, methylparaben, propylparaben, red 40, green 3

PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ALCOHOL FREE

ANTIVACITY

Fluoride Rinse

berry

Kills Germs that Cause Bad Breath

Helps Prevent Cavities

See proof in Your Sink of a Cleaner Mouth!  Contains Ingredients that Tint Food Particles.

16.9 FL OZ (500 mL)

IMPORTANT: Read directions for proper use.

INGREDIENTS AND APPEARANCE

ANTICAVITY FLUORIDE RINSE 
anticavity fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0893
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	.0221 kg  in 100 L

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (berry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0893-77	.5 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/16/2009

Labeler - Vi Jon (790752542)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture