ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
Dolgencorp, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Anticavity Rinse
893

Active ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

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.

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 mark 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

Other information

store at 20⁰ to 25⁰ C (68⁰-77⁰F)

Inactive ingredients

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

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

Sealed with printed neckband for your protection

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)

image description

ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwash

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

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55910-893-77	.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2008	06/03/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/15/2008	06/03/2021

Labeler - Dolgencorp, LLC (068331990)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(55910-893)

Revised: 6/2021

Document Id: 36b744ca-ef74-487d-b2d5-61b6752de70d

Set id: 80c644eb-ad7d-451b-aa82-d324b1f78fa1

Version: 8

Effective Time: 20210603

Dolgencorp, LLC

Anticavity Rinse893