Label: UP AND UP ANTICAVITY TOOTHPASTE WHITENING- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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

    Sodium Fluoride 0.243% (0.14% w/v fluoride ion)... Anticavity toothpaste
  • USE

    Helps protect against cavities
  • WARNINGS

    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.

  • Directions

    Adults and children 2 years and older      Brush teeth throughly, preferably after each meal, or at least twice a day, or as directed by your dentist. Do not swallow.

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

    Children under 2 years                                  Ask a dentist or physician
  • Inactive ingredients:

    Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Sodium Phosphate, Sodium Saccharin, Methyl Cellulose, Titanium Dioxide, Blue 1.
  • Principal Display Panel

    image of container

  • PURPOSE

    Anticavity toothpaste
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INGREDIENTS AND APPEARANCE
    UP AND UP ANTICAVITY TOOTHPASTE WHITENING  
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-082
    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)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINT (bold mint flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67659-082-021 in 1 CARTON
    1NDC:67659-082-01181.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/25/2010
    Labeler - Team Technologies, Inc (192339703)
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