Label: NATIVE WHITENING CANDY CANE- sodium fluoride paste, dentifrice

  • NDC Code(s): 69423-947-41, 69423-947-85
  • Packager: Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.243% (0.14% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warnings

    Keep out of reach of children under 6 yrs of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children’s brushing until good habits are established
    • children under 2 yrs.: ask a dentist
  • Inactive ingredients

    glycerin, water, hydrated silica, xylitol, flavor, mentha piperita (peppermint) oil, sodium cocoyl glutamate, xanthan gum, carrageenan, cocamidopropyl betaine, stevia rebaudiana extract, titanium dioxide

  • Questions?

    1-888-964-1211

  • SPL UNCLASSIFIED SECTION

    Distr. by Native

    San Francisco, CA 94111

  • PRINCIPAL DISPLAY PANEL - 116 g tube in carton

    WITH FLUORIDE

    WHITENS TEETH

    FRESHENS BREATH

    FIGHTS CAVITIES

    NATIVE

    FLUORIDE ANTICAVITY TOOTHPASTE

    WHITENING

    CANDY CANE

    NET WT 4.1 OZ (116 g)

    69423947

  • INGREDIENTS AND APPEARANCE
    NATIVE  WHITENING CANDY CANE
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-947
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-947-411 in 1 CARTON10/06/2020
    1116 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69423-947-851 in 1 CARTON10/06/2020
    224 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02110/06/2020
    Labeler - Procter & Gamble Manufacturing Company (004238200)
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