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 Type HUMAN OTC DRUG Item Code (Source) NDC:30142-004
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 10.4 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:30142-004-77 500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/18/2013
Labeler - Kroger Co (006999528)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(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