Label: WALGREEN SENSITIVE EXTRA WHITENING- potassium nitrate and sodium fluoride paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 18, 2016

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

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

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

  • USES

    • Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact
    • Aids in the prevention of dental cavities


  • WARNINGS

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

    Children under 12 years of age Consult a dentist or doctor

    Other informationStore in a cool, dry place.


  • Inactive ingredients

    Sorbitol, Silica, Water, Sodium Lauryl Sulphate, Flavor, Cellulose Gum,Titanium Dioxide, Sodium Benzoate, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin

  • PURPOSE


  • KEEP OUT OF REACH OF CHILDREN


  • Principal Display Panel

    image of container
  • INGREDIENTS AND APPEARANCE
    WALGREEN SENSITIVE EXTRA WHITENING 
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0632
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorwhite (Extra Whitening) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0632-72113 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/06/2006
    Labeler - Walgreen (008965063)
    Registrant - Team Technologies, Inc (192339703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goran Pharma Private Limited862174088manufacture(0363-0632)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!