ANTICAVITY RINSE- sodium fluoride mouthwash 
Demoulas 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 
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

adverse reactions section

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Bubblegum Blowout Anticavity Kids Fluoride Rinse.

Distributed by Demoulas Super Markets, Inc.

875 East Street, Tewksbuty, MA 01876

principal display panel

Sealed with printed neckband for your protection

"MORE FOR YOUR DOLLAR"

MARKET BASKET

ANTI-CAVITY

Compare to Act*

Bubble Gum Flavor

FLUORIDE RINSE

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:53942-004
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:53942-004-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/08/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/08/2013
Labeler - Demoulas Super Markets, Inc (007869647)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(53942-004)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(53942-004)

Revised: 1/2023
Document Id: 0c089f1e-59cc-4f78-826c-2fcb209b6e93
Set id: 6391ca2e-10e8-429d-a873-238a515f9c60
Version: 10
Effective Time: 20230111
 
Demoulas Super Markets, Inc