ANTICAVITY- sodium fluoride mouthwash 
CVS Pharmacy

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.

----------

Restoring Anticavity Fluoride Mouthwash
581.000-581AA-AB

Active ingredients

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

Adverse Reactions

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2017 CVS/pharmacy

CVS.com  1-800-SHOP CVS

CVS Quality

Money Back Guarantee

Disclaimer

This product is not manufactued or distributed by Chattem Inc., distributor of Act Restoring Anticavity Fluoride Mouthwas Cool Mint.

Principal display panel

CVS

Health

Compare to Act Restoring Fluoride Mouthwash Cool Mint*

Anticavitty

Restoring

Fluoride

Rinse

SODIUM FLUORIDE

Cooling Mint

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

IMPORTANT: Read directions for proper use

33.8 FL OZ (1L)

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-581
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:69842-581-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/24/2017
Labeler - CVS Pharmacy (062312574)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(69842-581)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(69842-581)

Revised: 7/2023
Document Id: ba76ba34-a9b7-4773-868e-b601a87bbdd6
Set id: 443a2510-e077-447e-a5ff-11cf50ca3ba7
Version: 13
Effective Time: 20230727
 
CVS Pharmacy