ANTICAVITY- sodium fluoride rinse 
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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Burn-Free Fluoride Anti-Cavity Mouthwash
971.001/971AB

Active ingredient

Sodium fluoride 0.02% (0.01% 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, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

Children under 6 years of age: consult a dentist or doctor

Other information

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

This product is not intended to replace brushing or flossing

Distributed by:

CVS Pharmacy Inc.

One CVS Drive

Woonsocket, RI 02895

(c)2021 CVS/pharmacy

CVS.com

1-800-SHOP CVS

CVS Quality money back guarantee

Principal display panel

CVS Health

Compare to Listerine Total Care Zero Anticavity Mouthwash*

Alcohol Free

Anticavity Fluoride

Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPCAL SOLUTION

6 Benefits:

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

IMPORTANT: read directions for proper use

1L (33.8 FL OZ)

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-548
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)  
sorbitol (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
THYMOL (UNII: 3J50XA376E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
menthol (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SPEARMINT OIL (UNII: C3M81465G5)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-548-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/20/2021
Labeler - CVS Pharmacy, Inc (062312574)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(69842-548)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(69842-548)

Revised: 4/2023
Document Id: f8f73418-e006-48b8-a1de-b151269a50c5
Set id: 344c9d00-ad82-46a9-83e9-68197e1a68bb
Version: 9
Effective Time: 20230425
 
CVS Pharmacy, Inc