ORAL ANTIVAVITY- sodium fluoride mouthwash 
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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Krogers, 576.001/576AC-AD

claims

Kroger

FROM OUR FAMILY TO YOURS

Refreshing

Mint

ALCOHOL FREE FLUORIDE MOUTHWASH

Active ingredient

Sodium fluoride 0.0219% (0.01% w/v fluoride ion)

Purpose

Anticavity

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, get medical help or contact a Poison Control Center Right Away

Directions

Adults and children 6 years of age and older:

Inactive ingredients

water, glycerin, flavor, cetlpyridinium chloride, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, propylene glycol, disodium phosphate, blue 1

Questions or comments?

1-800-632-6900

Claims

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

Disclaimer

CREST IS A REGISTERED TRADEMARK OF THE PROCTER & GAMBLE COMPANY, CINCINNATI, OHIO 45202.  THE PROCTER & GAMBLE COMPANY IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

Adverse Reactions

DISTRIBUTED BY THE KROGER CO., OHIO 452020

QUALITY GUARANTEE

www.kroger.com

principal display panel

COMPARE TO

the active ingredient of

CREST PRO-HEALTH COMPLETE

ANTICAVITY FLUORIDE RINSE

See Back Label

Kroger

Refreshing Mint

ALCOHOL-FREE

FLUORIDE MOUTHWASH

ANTICAVITY FLUORIDE RINSE

IMPORTANT: read directions for proper use.

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

33.8 FL OZ (1 L)

image description

ORAL ANTIVAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-576
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION10.41 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-576-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/06/2015
Labeler - Kroger Co (006999528)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(30142-576)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(30142-576)

Revised: 4/2022
Document Id: 32e82163-ce81-461f-b2c0-ef4245f59340
Set id: 932723b8-9875-4f37-8c11-018c94ae0ae1
Version: 11
Effective Time: 20220421
 
Kroger Co