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Western Family Whitening Plus Minty Fresh Mouthwash Anticavity

Dosage form: paste, dentifrice
Ingredients: Sodium Fluoride 2.43mg in 1g
Labeler: Western Family Foods, Inc
NDC Code: 55312-182

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 Whitening Plus Minty Fresh Mouthwash Fluoride Anticavity Toothpaste

Active Ingredient

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



Directions

Adults and children          Brush teeth thoroughly, 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, Water, Hydrated Silica, PEG-6, Sodium Lauryl Sulphate, Alcohol (1.14%), Flavor, Xanthan Gum, Carbomer, Sodium Benzoate, Titanium Dioxide, Tetrasodium Pyrophosphate, Sodium Saccharin, Triclosan, Blue 1, Yellow 4.

Principal Display Panel

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.

USE

Helps protect against cavities.

WESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-182
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 
WATER 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 300 
SODIUM LAURYL SULFATE 
ALCOHOL1.14 mg  in 1 g
XANTHAN GUM 
SODIUM BENZOATE 
TITANIUM DIOXIDE 
SODIUM PYROPHOSPHATE 
SACCHARIN SODIUM 
TRICLOSAN 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Striped Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55312-182-05181.4 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: 01/2011
Document Id: 7f6d7336-dcd2-43d1-a252-8d778d2f320b
Set id: 651124ba-d5c4-415c-9d7b-6642c9fbcb55
Version: 2
Effective Time: 20110115
 
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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