Label: THEORY FRESHNESS CARE ESSENTIAL MINT- sodium fluoride paste, dentifrice

  • NDC Code(s): 69423-919-37
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 17, 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, cocamidopropyl betaine, cellulose gum, flavor*, stevia rebaudiana extract, trisodium phosphate, sodium phosphate, xanthan gum

  • Questions?

    1-866-961-2375

  • PRINCIPAL DISPLAY PANEL - 104 g Tube Carton

    NET WT 3.7 OZ (104 g)

    theory.

    fluoride anticavity toothpaste

    FRESHNESS CARE

    ESSENTIAL MINT

    Designed with science in mind.
    Made with fluoride to remineralize
    enamel, prevent cavities, and nourish
    teeth. No extraneous ingredients.
    Made without dyes, parabens, and SLS.
    No added artificial flavors -
    only real mint.

    69423919

  • INGREDIENTS AND APPEARANCE
    THEORY  FRESHNESS CARE ESSENTIAL MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-919
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-919-371 in 1 CARTON01/05/2021
    1104 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 - The Procter & Gamble Manufacturing Company (004238200)
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