ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash 
CVS Pharmacy, 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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Drug Facts CVS 163.005/163AF-AG

Active Ingredient

Sodium fluoride 0.0221% (0.01% fluoride ion)

Purpose

Antcavity

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, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Other information

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
2017 CVS/pharmacy
www.cvs.com 1-800-shop-CVS

principal display panel

CVS Health

Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash

Anticavity Fluoride Mouthwash

SODIUM FLUORIDE

6 Benefits:

Eucalyptus Mint

Sealed with printed neckband for your protection. Do not use if broken or missing.

IMPORTANT: Read directions for proper use.

1 L (33.8 FL OZ)

image description

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-163
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)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MENTHOL (UNII: L7T10EIP3A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
THYMOL (UNII: 3J50XA376E)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-163-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2008
2NDC:59779-163-861000 mL in 1 PACKAGE; Type 0: Not a Combination Product09/15/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/15/2008
Labeler - CVS Pharmacy, Inc (062312574)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(59779-163)

Revised: 9/2023
Document Id: 9ff65334-17df-4272-85c7-110e409fffb2
Set id: b2f7490c-e2af-49df-b054-70fb4815f729
Version: 11
Effective Time: 20230927
 
CVS Pharmacy, Inc