ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid 
Retail Business Services, LLC

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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Alcohol Free Fluoride Violet Mint Mouthwash
482.001/482AB

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredients

Sodium fluoride 0.02% (0.0 1% 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, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Claims

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

Dislcaimer

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest® Pro-Health™ Complete Anticavity Fluoride Rinse.

**This product is not intended to replace brushing or flossing.

Adverse reaction

DISTRIBUTED BY: FODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

©2018 S&S Brands, LLC

Quality guaranteed or your money back.

Principal display panel

CAREONE

Compare to the Active Ingredient in Crest Pro-Health™ Advanced Anticavity Fluoride Mouthwash*

ALCOHOL FREE

FLUORIDE MOUTHWASH

ANTICAVITY

FLUORIDE RINSE

VIOLET MINT FLAVOR

KILLS BAD BREATH GERMS

HELPS PREVENT CAVITIES

HELPS STRENGTHEN ENAMEL

CLEANS TEETH**

FRESHENS BREATH

IMPORTANT: Read directions for proper use

33.8 FL OZ (1.05 QT) 1L

image description

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-482-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/2013
Labeler - Retail Business Services, LLC (967989935)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(72476-482)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(72476-482)

Revised: 7/2023
Document Id: 4f7fd6d2-b98f-49cd-8b61-d99528b4e891
Set id: 542e067a-c134-44c9-b962-f2a2b667b76f
Version: 16
Effective Time: 20230726
 
Retail Business Services, LLC