WESTERN FAMILY TARTAR CONTROL - sodium fluoride paste, dentifrice 
Western Family Foods, 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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Western Family Tartar Control Fluoride Toothpaste

Active Ingredient

Sodium Fluoride 0.243% (0.15% w/v fluoride ion)...Anticavity toothpaste



Helps protect against cavities.

As with all fluoride toothpastes, keep out of reach of children under 6 years of age.  If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Adults and children            Brush teeth throughly, preferably after
2 years and older               each meal, or at least twice a day, or as
                                            directed by your dentist.  Do not swallow.

Children under                    To minimize swallowing, use a pea-sized
6 years of age                    amount and supervise brushing until
                                             good habits are established.

Children under 2 years       Ask a dentist or physician.


Inactive Ingredients:

Sorbitol, Hydrated Silica, Water, PEG-6, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Titanium Dioxide, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin, FDC Blue 1

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image of container

WESTERN FAMILY TARTAR CONTROL 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-163
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Mint Paste) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-163-07232.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/24/2008
Labeler - Western Family Foods, Inc (192166072)

Revised: 3/2011
Document Id: 0b18bfbf-a029-4f60-8e4e-817f01da2b61
Set id: 62d3f848-894c-4aaf-8c59-7129d0379d07
Version: 2
Effective Time: 20110321
 
Western Family Foods, Inc