ANTICAVITY- sodium fluoride rinse 
Kroger Co

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

Active ingredient

Active ingredient

Sodium fluoride 0.055% (0.02% w/v fluoride ion)

Purpose

Purpose

Anticavity rinse

Use

Use aids in the prevention of dental cavities

Warnings

Warnings

Keep out of reach of children

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

Directions

Other information

Other information

Inactive ingredients

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

Adverse Reactions

Comments or Questions?

800-632-6900 or www. kroger.com

DISTRIBUTED BY

THE KORGER CO.

CINCINNATI, OH 45202

Principal Display Panel

Sealed with printed neckband for your protection.

IMPORTANT: read directions for proper use

Kroger

Quality Guaranteed

KIDS

Anticavity

Fluoride Rinse

strong cavity protection

alcohol free

helps strengthen teeth

helps prevent cavities

16.0 FL OZ

(500 mL)

bubblegum

Flavor

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION10.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
EDETATE CALCIUM DISODIUM ANHYDROUS 
CETYLPYRIDINIUM CHLORIDE 
EDETATE DISODIUM 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
POLOXAMER 407 
POLYSORBATE 80 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-004-77500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/18/2013
Labeler - Kroger Co (006999528)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(30142-004)

Revised: 1/2013
Document Id: 0192b11a-4819-49f8-8f1a-b9b524adc76d
Set id: 27a98b64-8369-4f3d-b487-d7ce98abc69f
Version: 1
Effective Time: 20130114
 
Kroger Co