Label: UP AND UP ANTICAVITY TOOTHPASTE WHITENING PLUS MOUTHWASH- 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 May 31, 2011

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  • Active Ingredient

    Sodium fluoride 0.243% (0.15% w/v fluoride ion)... Anticatity 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 thoroughly, 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, PEG-6, Sodium Lauryl Sulphate, Alcohol (1.14%), Flavor, Xanthan Gum, Carbomer, Sodium Benzoate, Titanium Dioxide, Tetrasodium Pyrophosphate, Sodium Saccharin, Triclosan, Blue 1, Yellow 4.
  • Principal Display Panel

    image of container
  • PURPOSE

    Anticatity toothpaste
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INGREDIENTS AND APPEARANCE
    UP AND UP ANTICAVITY TOOTHPASTE WHITENING PLUS MOUTHWASH 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-090
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M) 1.14 mg  in 1 g
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINT (Minty Fresh) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-090-021 in 1 CARTON
    1NDC:11673-090-01181.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/31/2011
    Labeler - Target Corporation (006961700)
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