ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid 
Meijer Distribution, 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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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

Purpose

Anticavity

Use

Use aids in the preveiontion of dental cavities

Warning

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

Directions

Adults and children 6 years of age and older:

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

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 Item Code (Source) NDC:41250-482
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41250-482-86 1000 mL in 1 BOTTLE, PLASTIC
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 Business Operations
Vi-Jon 790752542 manufacture(41250-482)

Revised: 10/2012
Document Id: 1405fa9a-1d48-4da6-8085-14e3728d2d07
Set id: c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea
Version: 1
Effective Time: 20121017
 
Meijer Distribution, Inc