ANTICAVITY FLUORIDE RINSE- sodium fluoride rinse
Wakefern Food Corp

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, Bubble Gum
004.001/004AE

Active Ingredient

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

Purpose

Anticavity 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 milliliters (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

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADA Statement

"The ADA Council on Scientific Affairs' Acceptance of ShopRite Anticavity Flouride Rinse is based on the finding that the product ie effective in helpnt to preven and reduce tooth decay, when used as directed"

Questions or Comments

This product is not manufactured or distributed by Chattem, Inc., dostributor of Act Anticavity Fluoride Rinse

Qw welcome your questions and comments.

Call: 1-800-ShopRite

E-mail: www.shoprite.com

Write:: Wakefern Food Corp.

600 York St.

Elizabeth, NJ 07027

Please provide product UPC and codes stamped on product

Adverse Reactions Section

DISTRIBUTED BY

WAKEFERN FOOD CORPORATION

5000 RIVERSIDE DRIVE

KEASBEY, NJ 08832

principal display panel

Compare to the active ingredient in ACT

Shop Rite

Anticavity

FLUORIDE

RINSE

FOR KIDS

Strong Cavity

Protection

Alcohol Free

BUBBLE GUM BLAST

ADA

ACCEPTED

American

Dental

Association

IMPORTANT: Read directions for proper use

18 FL OZ (532 mL)

image description

ANTICAVITY FLUORIDE RINSE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41190-104
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 (UNII: 25IH6R4SGF)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM (Bubble Gum Blast)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-104-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/19/2007	01/19/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/19/2007	01/19/2023

Labeler - Wakefern Food Corp (069722418)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(41190-104)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		088520668	manufacture(41190-104)

Revised: 1/2023

Document Id: 63385489-101a-422b-8b0e-1f1ddaa59e88

Set id: a0518f0e-6278-4a36-9875-14f78798b674

Version: 11

Effective Time: 20230119

Wakefern Food Corp

Anticavity Fluoride Rinse, Bubble Gum004.001/004AE