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Name:Binaca Fluoride Anticavity Mouthwash
Manufacturer:Dr. Fresh, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Binaca Fluoride Anticavity Mouthwash

BINACA FLUORIDE ANTICAVITY MOUTHWASH  - sodium fluoride liquid 
Dr. Fresh, 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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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


Question? Comments?

1-866-373-7374

comments@drfresh.com

www.drfresh.com

www.binaca.com

DR.Fresh

Distributed by:

USA - Dr. Fresh Inc.

Buena Park, CA 90620 USA

Canada - Dr. Fresh Inc.

Ontario, Canada L7C2T4

UK - Grosvenor Consumer Products Limited

25 Gore Road, Bumham Bucks SL1 8AB


Made in U.S.A.

Do not use if Carton is open seal underneath tube cap is missing or broken.

Alcohol Free

A Binaca Blast that lasts!

Binaca Fluoride

Anticavity Mouthwash

Peppermint Flavored

- Helps Prevent Cavities - Kills Bad Breath Germs - Freshens Breath

IMPORTANT: Read directions for proper use.

16 fl oz (473 mL)

DR.Fresh

Distributed by:

USA - Dr. Fresh Inc.

Buena Park, CA 90620 USA

Canada - Dr. Fresh Inc.

Ontario, Canada L7C2T4

UK - Grosvenor Consumer Products Limited

25 Gore Road, Burnham Bucks SL1 8AB

Made in U.S.A

Binaca Fluoride


BINACA FLUORIDE ANTICAVITY MOUTHWASH 
sodium fluoride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64893-500
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (SODIUM CATION) SODIUM FLUORIDE 0.05 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
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  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64893-500-00 473 mL in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 09/02/2010

Labeler - Dr. Fresh, Inc. (033059119)
Establishment
Name Address ID/FEI Operations
Dr. Fresh, Inc. 033059119 manufacture

Revised: 09/2010 Dr. Fresh, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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