Label: THE HUMBLECO NATURAL FRESH MINT- sodium fluoride paste, dentifrice

  • 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 May 29, 2018

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  • Drug Facts

  • Active ingredient

    Sodium fluoride 0.237%

    Purpose

    anticavity

  • Use/Indication

    aids in the prevention of dental cavities

  • Warnings

    When using this product

    if irriation occurs discontinue use.

    Keep out of reach of children

    under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contat a Poision Control Center right away.

  • Directions

    > adults and children 2 years of age and older:
    - apply toothpaste onto a toothbrush
    - 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). Supervise children as necessary until capable of using without supervision.
    > children under 2 years of age: Consult a dentist or doctor

  • Other information

    store below 25 O C (77 OF)

  • Contact/Questions:

    Call 1 (858) 876-5174

  • Inactive ingredients

    HYDROGENATED STARCH HYDROLYSATE, AQUA, HYDRATED SILICA, LAURYL GLUCOSIDE, XANTHAN GUM, MENTHA PIPERITA OIL, SODIUM FLUORIDE, ZINC GLUCONATE, MENTHOL, STEVIA REBAUDIANA EXTRACT, ALOE BARBADENSIS LEAF JUICE POWDER, SALVIA TRILOBA LEAF EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, COMMIPHORA MYRRHA RESIN EXTRACT, LIMONENE, CI 77891.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    THE HUMBLECO NATURAL FRESH MINT 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72299-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    MENTHOL (UNII: L7T10EIP3A)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    THREE-LOBE SAGE (UNII: 3V97D33N0K)  
    MYRRH (UNII: JC71GJ1F3L)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72299-001-0075 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2018
    Labeler - The Humble Company USA, Inc (080780354)
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