Label: UP AND UP SENSITIVE TOOTHPASTE ENAMEL STRENGTHENING FORMULA- 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 August 25, 2010

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  • Active Ingredients

    Potassium nitrate 5% ........................................Antihypersensitivity
    Sodium Fluoride 0.15% w/v fluoride ion............... Anticavity
  • 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

    If pain/ sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 12 years and older          Brush teeth thoroughly at least 1 minute after each meal or at least twice a day or as directed by your dentist. Be sure to brush sensitive areas of the teeth.

    Children under 12 years of age                         Consult a dentist or doctor

    Other information                                                Store in a cool, dry place.
  • Inactive ingredients:

    Sorbitol, Water, Silica, Glycerin, PEG-6, COCAMIDOPROPYL BETAINE, Xanthan Gum, Flavor, Sodium Saccharin, Titanium Dioxide, Sodium Hydroxide.
  • Principal Display Panel

    image of container
  • PURPOSE

    Antihypersensitivity, Anticavity

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INGREDIENTS AND APPEARANCE
    UP AND UP SENSITIVE TOOTHPASTE ENAMEL STRENGTHENING FORMULA 
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-080
    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 FLUORIDE1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (refreshing mint flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67659-080-021 in 1 CARTON
    1NDC:67659-080-01113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/25/2010
    Labeler - Team Technologies, Inc (192339703)
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