Label: UP AND UP ANTICAVITY TOOTHPASTE MULTI FUNCTION- stannous 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

    STANNOUS FLUORIDE 0.454%......................  ANTICAVITY, ANTIGINGIVITIS,
    (0.16% W/V FLUORIDE ION)                             ANTISENSITIVITY TOOTHPASTE 

  • USES

    • HELPS AID IN THE PREVENTION OF CAVITIES
    • HELPS PREVENT GINGIVITIS
    • HELPS CONTROL PLAQUE BACTERIA THAT CONTRIBUTE TO THE DEVELOPMENT OF GINGIVITIS
    • BUILD INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH TO COLD, HEAT, ACIDS, SWEETS OR CONTACT.
  • WARNINGS

    WARNINGS: WHEN USING THIS PRODUCT DO NOT USE FOR SENSITIVITY LONGER THAN FOUR WEEKS UNLESS RECOMMENDED BY A DENTIST. STOP USE AND ASK A DENTIST IF THE SENSITIVITY PROBLEM PERSISTS OR WORSENS. SENSITIVE TEETH MAY INDICATE A SERIOUS PROBLEM THAT MAY NEED PROMPT CARE. 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, PREFERABLY AFTER EACH MEAL,or at least twice a day,                                                                       or as directed by your dentist. DO NOT SWALLOW
    Children under 12                                         ASK A dentist or PHYSICIAN
    Other information                                         PRODUCTS CONTAINING STANNOUS FLUORIDE MAY PRODUCE SURFACE                                                                               STAINING OF THE TEETH. ADEQUATE TOOTHBRUSHING MAY PREVENT                                                                                   THESE STAIN WHICH ARE NOT HARMFUL OR PERMANENT.

  • Inactive ingredients:

    Sorbitol, Water, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, Glycerin, SODIUM LAURYL SULPHATE, flavor, ZINC LACTATE, PEG-6, CELLULOSE GUM, SODIUM PHOSPHATE, SODIUM GLUCONATE, Sodium Saccharin, Titanium Dioxide, BLUE 1, YELLOW 4.
  • Principal Display Panel

    image of container

  • PURPOSE

    ANTICAVITY, ANTIGINGIVITIS, ANTISENSITIVITY TOOTHPASTE

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INGREDIENTS AND APPEARANCE
    UP AND UP ANTICAVITY TOOTHPASTE MULTI FUNCTION 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-083
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) STANNOUS FLUORIDE4.54 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINT (clean mint flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67659-083-021 in 1 CARTON
    1NDC:67659-083-01170 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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