ORAL ANTIVAVITY- sodium fluoride mouthwash 
Amazon.Com 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.

----------

Whitening Anticavity Rinse
576.001/576AC

Active ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

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

Sealed with printed neckband for your protection.

DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

2021 Amazon.com, Inc. or its afiliated.

All rights reserved. Solimo and all related logos are are trademarks of Amazon.com, Inc or its affiliates.

SEALED WITH PRINTED NECKBAND FOR YOUR PORTECTION 

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

PRINCIPAL DISPLAY PANEL

SOLIMO

Anticavity Flouride Mouthwash

IMPORTANT: READ DIRECTIONS FOR PROPER USE

Refreshing Mint Flavor

1 L (33.8 FL OZ)

image description

PRINCIPAL DISPLAY PANEL

amazon basics

anticavity

fluoride

mouthwash

Alcohol Free

Refreshing Mint Flavor

IMPORTANT: READ DIRECTIONS FOR PROPER USE

33.8 fl oz (1 L)

image description

ORAL ANTIVAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-576
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)  
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72288-576-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/2018
Labeler - Amazon.Com Services LLC (128990418)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(72288-576)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(72288-576)

Revised: 9/2023
Document Id: 353aaa81-dafe-4d2b-b753-22c740ad054f
Set id: 03735abc-d1be-4ca0-a497-0a5c5f289402
Version: 5
Effective Time: 20230907
 
Amazon.Com Services LLC