Anticavity Fluoride Rinse by Onpoint, Inc. / Vi Jon Anticavity Mouthwash

Drug Details [pdf]

ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
Onpoint, Inc.

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 Mouthwash

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, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older:

use twice daily after brushing your teeth with toothpaste
vigorously swish 10 mL (2 teaspoonfuls) 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
supervise children as necessary until capable of using without supervision
children under 12 years of age: consult a dentist or doctor

Other information

store at controlled room temperature 20⁰ -25⁰ C (68⁰ - 77⁰ F)
cold weather may temporarily cloud this product

Inactive ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disosium phosphate, red 40, blue 1

This product is not manufacturd or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine Total Care Antivacity Mouthwash.*

Live Better products provide a simple way to look after yourself and your family. All of our products are crafted from high quality ingredients to exacting standards. Live Better is a great way to meed the health needs of your busy lifestyle. Live Better helps you be better.
Live Better, for life
DISTRIBUTED BY
ONPOINT, INC.
2 PARAGON DRIVE
MONTVALE, NJ 07645

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Live Better Anticavity Mouthwash

Sodium Fluoride ad Acidulated Phosphate Topical Solution

EUCALUPTUS MINT

Compare to the active ingrediet in Listerine Total Care Anticavity Mouthwash

HELPS PREVENT CAVITIES
RESTORES ENAMEL
HELPS STRENGTHEN TEETH
HELPS KILL GERMS THAT CAUSE BAD BREATH

IMPORTANT: READ DIRECTINS FOR PROPER USE.

1 L (33.8 fl oz)

163.004/163AE

image description

ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51143-163
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
sucralose (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 51143-163-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2010	01/13/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/16/2010	01/13/2020

Labeler - Onpoint, Inc. (001367366)

Registrant - Vi Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		790752542	manufacture(51143-163)

Revised: 1/2020

Document Id: d02eb820-d886-4216-975f-648b2a4fc9c9

Set id: 0b16fac2-853a-4d0a-a16c-df1b084013ec

Version: 5

Effective Time: 20200113