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Binaca Fluoride Anticavity Mouthwash

Dosage form: liquid
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: Dr. Fresh, Inc.
NDC Code: 64893-500

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.

Binaca Fluoride Anticavity Mouthwash

Active ingredient                                                                   
Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose: .Anticavity Rinse

Uses

 - Aids in the prevention of dental cavities

Keep out of reach of children under 6 years of age.

Warnings

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. Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters 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. - Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). - Supervise children as necessary untill capable of using without supervision. - Children under 6 years of age: Consult a dentist or doctor.

Other information Store at room temperature

Inactive ingredients
Water, Glycerine, PEG 40 hydrogenated castor oil, Xylitol, Poloxamer 407, Sorbitol, Peppermint Flavor, Sodium enzoate, Sodium saccharin, Cetylpyridinium chloride, Citric acid, Zinc gluconate, Acesulfame potassium, Calcium lactate, FDandCBlue#1


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BINACA FLUORIDE ANTICAVITY MOUTHWASH 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-500
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
XYLITOL 
POLOXAMER 407 
SORBITOL 
PEPPERMINT 
SACCHARIN SODIUM 
CETYLPYRIDINIUM CHLORIDE 
CITRIC ACID MONOHYDRATE 
ZINC GLUCONATE 
ACESULFAME POTASSIUM 
CALCIUM LACTATE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:64893-500-00473 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/02/2010
Labeler - Dr. Fresh, Inc. (078508990)
Establishment
NameAddressID/FEIOperations
Dr. Fresh, Inc.078508990manufacture(64893-500)

 
Dr. Fresh, Inc.

Medically reviewed on Jul 24, 2018

Further information

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

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