FLUORIDE RINSE FOR KIDS- sodium fluoride rinse
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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Anticavity Fluoride Rinse 004

Active ingredient

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

Purpose

Antiavity rinse

use

aids in the prevention of dental cavities

Warnings

for this product

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 milliters (10 mL mark on inside of cap): do not fill above the 10 mL mark
vigorously swish 10 milliliters 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

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Other information

store at room temperature

adverse reaction section

The ADA Council on Scientific Affairs Acceptance of ShopRite Anticavity Fluoride Rinse is based on the finding that the product is efective in helping to prevent and reduce tooth decay, when used as directed

Live Better products provide a simple way to look after yourself and your family. All of our products are crafted from high quailty ingredients too exacting standards.

Live Better is a great way to meet the health needs of your busy lifestyle. Live better helps you be better.

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DISTRIBUTED BY ONPOINT, INC

2 PARAGON DRIVE, MONTVALE, NJ 07645

004.002/004ae

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

LIVEBETTER

ADA

Accepted

American

Dental

Association

Anticavity

Fluoride

Rinse

for Kids

BUBBLE GUM FLAVOR

STRONG CAVITY PROTECTION
ALCOHOL FREE

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

18 FL OZ (532 mL)

image description

FLUORIDE RINSE FOR KIDS
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51143-004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
poloxamer 407 (UNII: TUF2IVW3M2)
polysorbate 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51143-004-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/08/2009	03/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/08/2009	03/02/2020

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

Registrant - Vi Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		790752542	manufacture(51143-004)

Revised: 3/2020

Document Id: 9c64935d-47f7-45cc-9d2e-82f6d7fd90a8

Set id: 14cde07f-71f6-43f7-84a6-06e8e5857092

Version: 8

Effective Time: 20200305

The Great Atlantic + Pacific Tea Company