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Anticavity Fluoride Rinse by Publix Super Markets, Inc

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 1mg in 1mL
Labeler: Publix Super Markets, Inc
NDC Code: 56062-163

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 Fluoride Mouthwash

Active ingredient

Sodium fluoride 0.0221% (0.01% w/v 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 toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and 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

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

Inactive ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disosium phosphate, 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 PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811 publix.com

Principal Display Panel

Publix

EUCALYPTUS MINT

anticavity

FLUORIDE MOUTHWASH

Sodium Fluoride and Acidulated Phosphate Topical Solution

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

Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash*

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

1 L (33.8 FL OZ)

163.004/163AE

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-163
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
SODIUM LAURYL SULFATE 
EUCALYPTOL 
METHYL SALICYLATE 
THYMOL 
PHOSPHORIC ACID 
sucralose 
MENTHOL 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:56062-163-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/20/2011
Labeler - Publix Super Markets, Inc (006922009)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture(56062-163)

 
Publix Super Markets, Inc

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Medically reviewed on Oct 4, 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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