ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid 
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.

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Basics_ Solimo 482.001/482AB  Anticavity Fluroide Rinse

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

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

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

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

2021 Amazon.com, Inc. or its affiliates.

All rights reserved. 

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SOLIMO

Anticavity Fluoride Mouthwash

Refreshing mint flavor

Alcohol free

1 L (33.8 FL OZ)

image description

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amazon basics

anticavity

fluoride mouthwash

Alcohol Free

Violet Mint Flavor

IMPORTANT: RED DIRECTIONS FOR PROPER USE

Compare to Crest Pro-health Anticavity Fluoride Mouthwash

33.8 FL OZ (1 L)

image description

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-482
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:72288-482-861000 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 (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(72288-482)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(72288-482)

Revised: 9/2023
Document Id: 1fe7c672-fedd-4e3c-978a-7e9202930e0a
Set id: 349eca80-2e0c-409b-af29-3235fdc0695b
Version: 7
Effective Time: 20230911
 
Amazon.Com Services LLC