ANTICAVITY RINSE- sodium fluoride mouthwash 
Publix Super Markets, 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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Anticavity Fluoride Rinse, Bubble Gum 
004.002/004AE

Active ingredient

Sodium Fluoride 0.05% (0.2% w/v fluoride ion)        

Purpose

Anticavity Rinse

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, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

store at room temperature

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxomer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

DISCLAIMER

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

PUBLIX GUARANTEE:

COMPLETE SATISFACTION OR YOUR MONEY BACK

ADVERSE REACTION

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

publix.com

principal display panel

Publix

ANTICAVITY

kids

FLUORIDE RINSE

ADA

Accepted

American

Dental

Association

Helps prevent cavities

*COMPARE TO THE ACTIVE INGREDIENT OF ACT

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

18 FL OZ (532 mL)

image description

ANTICAVITY RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-004-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/26/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/26/2010
Labeler - Publix Super Markets, Inc., (006922009)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(56062-004)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(56062-004)

Revised: 1/2023
Document Id: 75e20ee2-e626-48dc-913c-8cc968e6fd6d
Set id: 60a309f5-f567-45e2-b3ca-f1690c516a69
Version: 14
Effective Time: 20230111
 
Publix Super Markets, Inc.,