Label: ARC ENAMEL PROTECTION- sodium fluoride paste, dentifrice

  • NDC Code(s): 69423-785-40
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.243% (0.15% 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

    sorbitol, water, hydrated silica, sodium lauryl sulfate, cellulose gum, flavor, sodium phosphate, trisodium phosphate, sodium saccharin, carbomer, sodium benzoate, red 40

  • Questions?

    1-866-989-3951

  • SPL UNCLASSIFIED SECTION

    DISTR.BY PROCTER & GAMBLE

    CINCINNATI, OH 45202

    2022 P&G

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    ARC

    ENAMEL PROTECTION

    FLUORIDE TOOTHPASTE

    HAPPY HOUR

    STRAWBERRY DAIQUIRI

    NET WT 4.0 OZ (113 g)

    69423-785

  • INGREDIENTS AND APPEARANCE
    ARC  ENAMEL PROTECTION
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-785
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-785-401 in 1 CARTON12/31/2022
    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 DrugM02112/31/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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