Label: THE HUMBLE CO. KIT- sodium fluoride kit

  • NDC Code(s): 72299-024-01, 72299-025-01
  • Packager: The Humble Company North America Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Sodium flouride 0.243% (0.15% w/v fluoride ion)

    Purpose

    Anticavity Toothpaste

  • Use

    aids in the prevention of dental cavities

  • Warning

    Keep out of reach of children under 6 years 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 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.
     Children under 6 years of age  Instuct in good brushing and rinsing habits (to minimize swallowing), Supervise children as necessary until capable of using without supervision. 
     Children under 2 years of age  Consult a dentist a doctor. 

  • Other information

    store below 25°C (77°F)

  • Inactive ingredients

    silica, deionized water, sorbitol, glycerine, sodium lauryl sulfate, sodium carboxymethyl cellulose, mint flavour, hythyl cellulose, sodium fluoride, sodium saccharin, titanium dioxide, benzoate sodium

  • Questions?

    Call (619) 940-6502

  • Package Labeling:Kit

    Kit

  • Package Labeling:

    Outer PackageBrush

  • INGREDIENTS AND APPEARANCE
    THE HUMBLE CO. KIT 
    sodium fluoride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72299-024
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72299-024-011 in 1 KIT02/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 6 g
    Part 1 of 1
    HUMBLE CO FRESH MINT 
    sodium fluoride paste
    Product Information
    Item Code (Source)NDC:72299-025
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72299-025-016 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/01/2022
    Labeler - The Humble Company North America Inc (010966342)
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