ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

Anticavity Fluoride Rinse by

Drug Labeling and Warnings

Anticavity Fluoride Rinse by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, LLC, 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 a toothpaste

remove cap

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

vigorously swish 10 milliliter 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

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

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerin Smart Rinse

GENERAL PRECAUTIONS

Sealed with printed neckband for your protection

ADVERSE REACTIONS

Distributed by Dolgencorp, LLC
100 Mission Ridge
Goodlettsville, TN 37072

100% Guaranteed  (888)309-9030

PRINCIPAL DISPLAY PANEL

Anticavity

Fluoride Rinse

For Kids

Compare to Listerine Smart Rinse

Berry flavor

Alcohol-Free

IMPORTANT: Read directions for proper use

500 mL (19.9 FL OZ)

INGREDIENTS AND APPEARANCE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-893
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

Inactive Ingredients
Ingredient Name	Strength
PHOSPHORIC ACID (UNII: E4GA8884NN)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY (Berry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-893-77	.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	07/15/2008

Labeler - Dolgencorp, LLC (068331990)

Registrant - Vi Jon (790752542)

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