Dr. Fresh Oral Care

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76g in 100g
Labeler: Dr. Fresh, Inc
NDC Code: 64893-320

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.

Dr. Fresh Oral Care Kit

Active Ingredient


Sodium Monofluorophosphate (0.76%)

Purpose

Anticavity

Use

helps protect against cavities.

Warnings


If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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

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)

Drug Product Label

Product Outer Container Label

DR. FRESH ORAL CARE 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-320
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
GLYCERIN 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM 
SORBITOL 
SODIUM PYROPHOSPHATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:64893-320-011 TUBE (TUBE) in 1 PACKAGE
124 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/04/2010
Labeler - Dr. Fresh, Inc (033059119)

Revised: 09/2011
 
Dr. Fresh, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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