ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
The Great Atlantic + Pacific Tea Company

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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Live Better 213.002-213AE rev 2

Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warning

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

• adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
• remove cap
• pour 10 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
• vigorously swish 10 milliliters of rinse between your teeth for 1 minute 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

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, green 3, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5

Other information

• store at room temperature

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 meet 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
LiveBetter
Anticavity Fluoride Rinse
MINT FLAVOR
•STRONG CAVITY PROTECTION
•ALCOHOL FREE
IMPORTANT:
READ DIRECTIONS FOR PROPER USE.
18 FL OZ (532 mL)

image description

ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51143-213
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.05 kg in 100 L

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51143-213-44	.532 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/12/2010	05/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	11/12/2010	05/27/2020

Labeler - The Great Atlantic + Pacific Tea Company (001367366)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(51143-213)

Revised: 5/2020

Document Id: f7d6d3a0-cd42-4445-aa76-e50d5ec5753e

Set id: 2f9598e5-22be-4a5e-900d-4d77a8f11aab

Version: 4

Effective Time: 20200527

The Great Atlantic + Pacific Tea Company