Western Family Cavity Control

Dosage form: paste, dentifrice
Ingredients: Sodium Fluoride 2.43mg in 1g
Labeler: Western Family Foods, Inc
NDC Code: 55312-164

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.

Western Family Cavity 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, Sodium Saccharin

Principal Display Panel

WESTERN FAMILY CAVITY CONTROL 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-164
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
SILICON DIOXIDE 
WATER 
POLYETHYLENE GLYCOL 300 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM BENZOATE 
TITANIUM DIOXIDE 
SODIUM PYROPHOSPHATE 
SACCHARIN SODIUM 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Cool Fresh Paste) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55312-164-07232.4 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: 03/2011
 
Western Family Foods, 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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