WESTERN FAMILY COMPLETE 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 Complete Whitening Fluoride Anticavity 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
6 years and older               each meal, or at least twice a day, or as
                                            directed by your dentist.  Do not swallow.

Children between                To minimize swallowing, use a pea-sized
6 and 12 years                    amount and supervise brushing until
                                             good habits are established.

Children under 6 years       Ask a dentist or physician.


Inactive Ingredients:

Sorbitol, Silica, Water, Glycerin, Sodium Lauryl Sulfate, Zinc Citrate, Titanium Dioxide, Cellulose Gum, Flavor, PVP, Sodium Benzoate, Tetrasodium Pyrophosphate, Sodium Saccharine, Sodium Hydroxide, Carageenan, Mica, FDC Blue No.1.

Principal Display Panel

image of container

WESTERN FAMILY COMPLETE WHITENING 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-003
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ZINC CITRATE (UNII: K72I3DEX9B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
MICA (UNII: V8A1AW0880)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-003-01181.4 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: 1/2011
Document Id: e9de92b1-628f-4d40-b8f9-e4957827d8c7
Set id: 082d3822-cd16-4394-9aca-e4753fd8e610
Version: 1
Effective Time: 20110110
 
Western Family Foods, Inc