ALCOHOL-FREE ANTICAVITY - sodium fluoride liquid
Meijer Distribution, Inc

Drug Facts

Claims

Sealed with printed neckband for your protection

Claims

Promotes fresh breath while fighting cavities

Alcohol-free formula will not burn as it helps kill germs

Active ingredients

Active Ingredient

Sodium fluoride 1.1219% (0.0 w/v fluoride ion)

Purpose

Anticavity

Use

Use aids in the preveiontion of dental cavities

Warning

Keep out of reach of children

Keep our 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 6 years of age and older:

use twice daily after brushing your teeth with a 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
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

Inactive ingredients water, glycerin, flavor, cetylpyridinium chloride, phosphoric acid, methylparaben, sodium saccharin, poloxamer 407, propylparaben, propylene glycol, disodium phosphate, red 33, green3

Claims

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.

Dislcaimer

Ths product is not manufactured or distributed by Procter + Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse.

Adverse Reaction

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

2929 WALKER AVE NW

GRAND RAPIDS, MI 49544

www.meijer.com

Principal Display panel

Meijer

Alcohol-Free

ANTICAVITY

FLUORIDE MOUTH RINSE

Helps prevent cavities
Helps strengthen enamel
Helps clean the entire mouth
Helps kiss germs that cause bad breath
No alcohol burn

VIOLET MINT

IMPORTANT: read directiosn for proper use

1 L (33.8 FL OZ)

image description

ALCOHOL-FREE ANTICAVITY
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	41250-482
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	0.1 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water
GLYCERIN
CETYLPYRIDINIUM CHLORIDE
PHOSPHORIC ACID
METHYLPARABEN
SACCHARIN SODIUM DIHYDRATE
POLOXAMER 407
PROPYLPARABEN
PROPYLENE GLYCOL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
D&C RED NO. 33
FD&C GREEN NO. 3

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	41250-482-86	1000 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/22/2012

Labeler - Meijer Distribution, Inc (006959555)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Operations
Vi-Jon		790752542	manufacture

Revised: 10/2012Meijer Distribution, Inc