Label: CARDINAL HEALTH FLUORIDE ANTICAVITY- fluoride anticavity toothpaste 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 December 30, 2019

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  • Drug Facts:

    NDC (63517-016-96)

  • Active Ingredient:

    Sodium fluoride - 0.243% w/w

  • Purpose

    Anticavity toothpaste

  • Uses:

    • Aids in the prevention of dental decay
  • Warnings:

    • If you accidentally swallow more than used for brushing ,seek medical help or contact a Poison Control Center right away.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children under 6 years of age.

  • Directions:

    • Adults and Children 2 years of age and older: Brush teeth thoroughly,  after meals or at least twice a day, or as directed by a dentist or physician.
    • Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing).
    • Supervise children as necessary until capable of using without supervision.
    • Chlidren under 2 years of age: Consult a dentist or physician.
  • Inactive ingredients:

    Cellulose Gum, Flavor, Disodium Phosphate,  and FD&C Blue No. 1, Glycerin, Hydrated Silica, PEG 6, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water

  • Principal Display Panel - .85oz  144 count Box

    Principal Display Panel - .85oz 144 count Box

    anticavity toothpaste with fluoride

    ADA accepted

    Principal Display Panel - .85oz 144 count Box

  • Principal Display Panel .85 oz -Tube

    anticavity toothpaste with fluoride

    Cardinal Health                      net wt. 0.85oz ( 24g)

    Principal Display Panel .85 oz -Tube

  • INGREDIENTS AND APPEARANCE
    CARDINAL HEALTH FLUORIDE ANTICAVITY 
    fluoride anticavity toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PEG-6 STEARATE (UNII: 8LQC57C6B0)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63517-016-96144 in 1 CASE09/09/2013
    124 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/09/2013
    Labeler - Cardinal Health (961027315)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(63517-016)
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