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Anticavity by Demoulas Super Markets, Inc.

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.1mg in 1mL
Labeler: Demoulas Super Markets, Inc.
NDC Code: 53942-163

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.

Anticavity Mouthwash

Active Ingredient

Sodium Fluoride 0.0221% (0.01% 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  
• use twice daily after brushing your teeth with a toothpaste
• vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• supervise children as necessary until capable of using without supervision
• children under 12 years of age: consult a dentist or doctor

Inactive ingredients

water, sorbitol solution, alcohol (21.6%), flavors, poloxamer 407, sodium lauryl sulfate,
phosphoric acid, sucralose and/or sodium saccharin, dibasic sodium phosphate, D+C red no. 33, FD+C blue no. 1, FD+C yellow no. 6

Other information

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

*This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine Total Care

DISTRIBUTED BY
DEMOULAS SUPER MARKETS, INC
875 EAST STREET
TEWKSBURY, MA 01876

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

Sealed With Printed Neckband For Your Protection

MARKET BASKET

MORE FOR YOUR DOLLAR

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.

1L (33.8 FL OZ)

163.004/163AE

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-163
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
ALCOHOL 
POLOXAMER 407 
SODIUM LAURYL SULFATE 
PHOSPHORIC ACID 
SODIUM PHOSPHATE, DIBASIC 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage Description
1NDC:53942-163-861000 mL in 1 BOTTLE, PLASTIC
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 (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture(53942-163)

 
Demoulas Super Markets, Inc.

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Medically reviewed on Oct 5, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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