ANTICAVITY- 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 Mouthwash 
163.005/AF-AG

Active Ingredient

Sodium fluoride 0.02% w/v (0.01% w/v fluoride ion)

Purpose

Anticavity

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, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older  

Other information

• store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
• cold weather may temporarily cloud this product

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

DEMOULAS SUPER MARKETS, INC

875 EAST STREET

TEWKSBURY, MA 01876

DSP-TN-15000 DSP-MO-34 SDS-TN-15012

principal panel display

"More for your dollar"

MARKET BASKET

Sealed With Printed Neckband For Your Protection

MARKET BASKET

Compare to Listerine Total Care Anticavity Mouthwash*

ANTICAVITY MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

Eucalyptus Mint

• Helps prevent cavities
• Helps strengthen teeth
• Helps kill germs that cause bad breath
• Freshens breath
• Restores enamel

IMPORTANT: Read directions for proper use.

Sealed With Printed Neckband For Your Protection

1L (33.8 FL OZ)

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-163
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 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:53942-163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/13/2006
Labeler - Demoulas Super Markets, Inc. (007869647)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(53942-163)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(53942-163)

Revised: 12/2022
Document Id: b219eab9-b352-42eb-8023-2a238c33067e
Set id: c28c3475-efbb-4099-83ab-ab91bac9dfc3
Version: 12
Effective Time: 20221220
 
Demoulas Super Markets, Inc.