Label: CARDINAL HEALTH- sodium fluoride paste, dentifrice

  • NDC Code(s): 63517-070-21
  • Packager: Cardinal Health 200, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2023

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  • Active ingredient

    Sodium Fluoride 0.24% (0.15% w/v Fluoride Ion)

  • Purpose

    Anticavity toothpaste

  • Uses

    Aids in the prevention of dental cavities

  • Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children under 6yrs. of age. If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Control Center immediately.

  • Directions:

    Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or directed by a dentist or physician. Instruct children under 6yrs of age in good brushing and rinsing habits (to minimize swallowing). Use a pea-size amount for children under 6. Supervise children as necessary until capable of using without supervision. Children under 2 yrs. of age: Consult a dentist or physician.

  • Inactive Ingredients:

    Sorbitol, Hydrated Silica, Water, Glycerin, PEG 12, Sodium Lauryl Sulfate, Titanium Dioxide, Cellulose Gum, Flavor, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, FD&C Blue #1

  • Principal Display

    anticavity toothpaste with fluoride

    ADA Accepted American Dental Association

    Cardinal Health™

    net wt 0.85 oz (24 g)

    NDC 63517-0702-1

    REF OC-TPASTE

    Distributed by: Cardinal Health, Waukegan, IL USA 60085

    Rev.A 2020-11 • OC-TPASTE (F)

    © 2020 Cardinal Health. All Rights Reserved.

    cardinalhealth.com/symbolsglossary

    Cardinal_Toothpaste_image.jpg

  • INGREDIENTS AND APPEARANCE
    CARDINAL HEALTH 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-070
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINT (UNII: FV98Z8GITP)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63517-070-2124 g in 1 TUBE; Type 0: Not a Combination Product01/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/04/2021
    Labeler - Cardinal Health 200, LLC (961027315)
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