ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash 
Publix Super Markets, Inc

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Anticavity Fluoride Mouthwash
163.005/163AF/AG

Active ingredient

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity

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 12 years of age and older:

Other information

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

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

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811 publix.com

principal display panel

Publix

EUCALYPTUS MINT

anticavity

FLUORIDE MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash*

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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:56062-163
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 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:56062-163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02107/20/2011
Labeler - Publix Super Markets, Inc (006922009)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(56062-163)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(56062-163)

Revised: 10/2023
Document Id: e7d10ca4-4f30-4427-828c-54fd27c9da2c
Set id: cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb
Version: 11
Effective Time: 20231013
 
Publix Super Markets, Inc