ANTICAVITY- sodium fluoride mouthwash 
United Natural Foods, Inc. dba UNFI

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Restoring Anticavity Fluoride Mouthwash
581.000/581AC

Active ingredient

Sodium fluoride 0.02% (0.009% 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, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Tamper Evident Statement

Sealed With Printed Neckband For Your Protection

Disclaimer

*This product is not manufactured or distributed by Chattem Inc., distributor of Act Restoring Anticavity Mouthwash Cool Mint

Adverse reaction

Like it or let us make it right.

That is our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

Principal panel display

compare to Act Restoring® Anticavity Fluoride Mouthwash Cool Mint active ingredient*

EQUALINE®

restoring

anticavity

fluoride

mouthwash

refreshing mint

IMPORTANT: READ DIRECTIONS FOR PROPER USE

33.8 FL OZ (1.05 QT) 1 L

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-581
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)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-581-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02110/26/2020
Labeler - United Natural Foods, Inc. dba UNFI (943556183)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(41163-581)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(41163-581)

Revised: 11/2023
Document Id: a7e4b8a8-53f3-4e31-a0a4-1c37751efa9a
Set id: 8283cea0-7b62-4796-8763-6654039664cd
Version: 7
Effective Time: 20231116
 
United Natural Foods, Inc. dba UNFI