ANTICAVITY- sodium fluoride rinse 
Demoulas

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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Market Basket 971.001-971AB

Active Ingredients

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:

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

Disclaimer

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

Adverse reactions section

DISTRIBUTED BY DEMOULAS SUPER MARKETS, INC.

875 East Street

Tewksbury, MA 01876 

"MORE FOR YOUR DOLLAR"

MARKET BASKET

Compare to Listerine Total Care Zero Alcohol Mouthwash

FLOURIDE

ANTI-CAVITY MOUTHWASH

Sodium fluoride and Acidulated Phosphate Topical Solution

Fresh Mint

IMPORTANT: Read directions for proper use.

Sealed With Printed Neckband For our Protection

1L (33.8 FL OZ)

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-971
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 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:53942-971-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/04/2022
Labeler - Demoulas (007869647)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(53942-971)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(53942-971)

Revised: 4/2022
Document Id: 9c168522-e9c6-4415-8b1b-a128f3699b95
Set id: 096e6a1d-316b-432a-bf27-70e8a13337cc
Version: 1
Effective Time: 20220408
 
Demoulas