WALGREENS MAXIMUM STRENGTH SENSITIVE FLUORIDE - potassium nitrate and sodium fluoride paste 
Walgreens

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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Walgreen Maximum Strength Sensitive Toothpaste

Active Ingredient

Potassium nitrate 5%........................................... Antihypersensitivity

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

When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor. Stop and ask a dentist if problems persists or worsens. Sensitive teeth may indicate a serious problem that may require prompt care by a dentist. Keep out of reach of children. If you accidentally swallow more that used for brushing seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children     Brush teeth for at least one minute, preferably after
12 years and older      each meal, or at least twice a day or as directed by     
                             
your dentist. Be sure to brush sensitive areas.

Children under          
Consult a dentist or doctor
12 years of age            

Other information
      
Store in a cool, dry place.

USE

Inactive Ingredients

Sorbitol,Water, Silica, Sodium Lauryl Sulphate, Flavor, Cellulose Gum,Titanium Dioxide, Sodium Benzoate, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin, FDC Blue No. 1, DC Yellow No.10



Principal Display Panel

image of container

WALGREENS MAXIMUM STRENGTH SENSITIVE FLUORIDE 
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0631
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM NITRATE5 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (FRESH MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0631-09113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/06/2006
Labeler - Walgreens (008965063)

Revised: 4/2011
Document Id: 15482811-438f-44dd-97a3-a3d4eb07a609
Set id: a9585342-fb58-431a-9e16-7b3ca235f6b3
Version: 1
Effective Time: 20110415
 
Walgreens