WESTERN FAMILY WHITENING - 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 Whitening 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, Silica, Water, PEG-6, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Titanium Dioxide, Sodium Phosphate, Sodium Saccharine

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WESTERN FAMILY WHITENING 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-162
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)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Mint Paste) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-162-05181.4 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: 4baccc50-7a20-4e0a-85b7-528b2973ff6a
Set id: c1833e28-1722-44ad-a2dd-86ae8868110a
Version: 1
Effective Time: 20110307
 
Western Family Foods, Inc