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

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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Anticavity Fluoride Rinse, Mint
213.001/213AE rev 2

Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warning

for this product

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions 

Other information

Inactve ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Sealed with printed Neckband for your protection

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse.

Like it or Let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

Principal Panel Display

NDC 41163-213-44

comapre to Act Anticavity Fluoride Rinse active ingredient*

EQUALINE

anticavity

fluoride

rinse

mint

INPORTANT: READ DIRECTIONS FOR PROPER USE.

18FL OZ (532mL)

image description

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-213
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
MENTHOL (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
potassium sorbate (UNII: 1VPU26JZZ4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-213-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/14/2009
Labeler - United Natural Foods, Inc. dba UNFI (943556183)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(41163-213)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(41163-213)

Revised: 5/2023
Document Id: 08df56da-9762-4ad2-8d0e-eb030bed08c4
Set id: e696038c-182e-4325-9b90-87fe498d9f67
Version: 5
Effective Time: 20230511
 
United Natural Foods, Inc. dba UNFI