Label: ARC WHITENING- sodium fluoride paste, dentifrice

  • NDC Code(s): 69423-889-40
  • Packager: Procter & Gamble Manufacturing Company
  • 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 April 27, 2022

If you are a consumer or patient please visit this version.

  • 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 finalpart35501/05/2021
    Labeler - Procter & Gamble Manufacturing Company (004238200)