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


Binaca Anticavity Fluoride Toothpaste Peppermint

BINACA ANTICAVITY FLOURIDE TOOTHPASTE PEPPERMINT  - sodium monofluorophosphate paste 
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 Anticavity Fluoride Toothpaste Peppermint

Active Ingredient                                             Purpose
Sodium Monofluorophosphate (0.76%)..............Anticavity

Use: helps protect against cavities.

Warnings Keep out of reach of children under 6 years of age.  If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients: Calcium Carbonate, Carboxymethyl Cellulose, Flavor, Glycerin, Hydrated Silica, Sodium Benzoate, Sodium Lauryl Sulphate, Sodium Saccharin, Sorbitol, Tetrasodium Pyrophosphate, Water.

Directions: Adults and children 2 years of age and older:
brush teeth thoroughly after meals or at least twice a day as directed by a dentist or physician.  Do not swallow.  To minimize swallowing use a pea-sized amount in children under 6.  Supervise children's brushing until good habits are established. 

Children under 2 years: ask a dentist.

For clean and healthy teeth: See  your dentist on a regular basis for a professional cleaning.  Use dental floss daily.


Questions or Comments?  Call toll-free 1-866-373-7374 or visit us at www.drfresh.com and www.binaca.com

Made in Malaysia in a GMP Certified Facility

Distributed by:
Dr. fresh

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

Brand Trusted Since 1890

A Binaca Blast that lasts

Binaca
Anticavity Flouride Toothpaste

Peppermint

NET WT. .85 OZ (24g)

BinacaToothpaste PDP


BINACA ANTICAVITY FLOURIDE TOOTHPASTE PEPPERMINT 
sodium monofluorophosphate paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64893-001
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 0.76 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE  
GLYCERIN  
SODIUM BENZOATE  
SODIUM LAURYL SULFATE  
SACCHARIN SODIUM  
SORBITOL  
SODIUM PYROPHOSPHATE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64893-001-24 24 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 05/04/2010

Labeler - Dr. Fresh, Inc (033059119)
Establishment
Name Address ID/FEI Operations
American Lion Toothpaste Manufacturing Sdn Bhd 652244161 manufacture

Revised: 05/2010 Dr. Fresh, Inc



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


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