Label: MADE BY DENTISTS ULTRA WHITENING FRESH MINT- sodium fluoride paste

  • NDC Code(s): 75065-027-06, 75065-027-07
  • Packager: MADE BY DENTISTS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 15, 2024

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  • Drug Facts

  • Active ingredient:

    Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

    Purpose

    Anticavity 

  • Use:

    Aids in the prevention of cavities.

  • Warnings:

    Keep out of reach of children under 6 years of age.

    If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), and only use a pea size amount.
    • Supervise children as necessary until capable of using without supervision.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Inactive ingredients:

    Water (Aqua), Sorbitol, Hydrated Silica, Xylitol, Flavor, Cocamidopropyl Betaine, Cellulose Gum, Pentasodium Triphosphate, Titanium Dioxide, Sordium Saccharin, Potassium Sorbate, Hydrogen Peroxide, Sodium Bicarbonate

  • Questions or comments?

    + 1 (646) 980-6461

  • Label 75065-027-06

    Labell.jpgLabel2.jpg

  • Label 75065-027-07

    LabelLabel tube

  • INGREDIENTS AND APPEARANCE
    MADE BY DENTISTS ULTRA WHITENING FRESH MINT 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75065-027
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75065-027-061 in 1 CARTON02/22/2024
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:75065-027-071 in 1 CARTON02/22/2024
    220 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/22/2024
    Labeler - MADE BY DENTISTS INC (117405870)
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