ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid 
Liberty Procurement, 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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Alcohol Free Fluoride Violet Mint Mouthwash
482.001/482AB

Active ingredient

Sodium fluoride 0.02%

(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, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

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

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

ALCOHOL FREE

COREVALUES

Anticavity MOUTWASH FLUORIDE RINSE

Distributed by

Liberty Procurement, Inc

650 Liberty Ave

Union, NJ 07083 USA

principal display panel

SEALED WITH

PRINTED NECK BAND FOR YOUR PROTECTION

ALCOHOL FREE

COREVALUES

*Compare to the active ingredient in Crest Pro-Health Complete

Anticavity

MOUTHWASH

FLUOIRDE RINSE

Violet Mint

IMPORTANT: Read directions for proper use.

1L (33.8 FL OZ)

image description

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 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:63940-482-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/28/2016
Labeler - Liberty Procurement, Inc (804085293)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(63940-482)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(63940-482)

Revised: 9/2023
Document Id: 44e1e31c-7a57-42d4-8152-d0be1ef7fbd9
Set id: 5818186a-b9d6-4164-99f1-cf70edaddb25
Version: 16
Effective Time: 20230927
 
Liberty Procurement, Inc