Label: ARC WHITENING- sodium fluoride paste, dentifrice

  • NDC Code(s): 69423-889-40
  • Packager: Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 16, 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, charcoal powder, sodium cocoyl glutamate, xanthan gum, carrageenan, cocamidopropyl betaine, stevia rebaudiana extract

  • Questions?

    1-866-989-3951

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 113 g tube in carton

    ARC

    WHITENING

    FLUORIDE TOOTHPASTE

    CHARCOAL

    NET WT 4.0 OZ (113g)

    ARC Whitening Toothpaste Charcoal

  • INGREDIENTS AND APPEARANCE
    ARC  WHITENING
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-889
    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
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    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)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorblackScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-889-401 in 1 CARTON01/05/2021
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/05/2021
    Labeler - Procter & Gamble Manufacturing Company (004238200)
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