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Anticavity by Demoulas Super Markets, Inc.

Medically reviewed on February 15, 2018

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 999.5mL in 100L
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.

Drug Facts

Active Ingredient
Sodium Fluoride 0.0221% (0.01% Fluoride ion)

Purpose
Anticavity

Use •aids in the prevention of dental cavities

Warning

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
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)
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) SODIUM FLUORIDE999.5 mL  in 100 L
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:53942-163-861 L 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

 
Demoulas Super Markets, Inc.

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Further information

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

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