Label: UNPASTE- zero waste fluoride mint tooth tabs tablet, chewable

  • NDC Code(s): 74355-555-11, 74355-555-12, 74355-555-13, 74355-555-14
  • Packager: Avespan LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 24, 2024

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  • Active Ingredient(s)

    Sodium Fluoride 0.62mg (28 mg flouride ion)

  • Purpose

    Anti-cavity

  • Use

    aids in the prevention of dental cavities

  • Warnings

    • When using this product, if irritation or sensitivity occurs discontinue use.
    • Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
  • WHEN USING

    When using this product, if irritation or sensitivity occurs discontinue use.

  • KEEP OUT OF REACH OF CHILDREN

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 6 years of age and older; chew one tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • Do not swallow the tablet.
    • Supervise children under 6 years of age for brushing and rinsing.
  • Other information

    Store at 25-30°C (68-77°F). Protect from excessive moisture.

  • Inactive ingredients

    Microcrystalline Cellulose, Sodium bicarbonate (Baking Soda), Silica, Sodium Lauryl Glutamate, Magnesium Stearate, Natural Mint Flavor, Menthol, Xanthan Gum, Stevia (Stevioside), Citric Acid

  • Package Label - Principal Display Panel

    Mint 125125 tabs, NDC: 74355-555-12

  • INGREDIENTS AND APPEARANCE
    UNPASTE 
    zero waste fluoride mint tooth tabs tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74355-555
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.62 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEVIA LEAF (UNII: 6TC6NN0876)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MINT (UNII: FV98Z8GITP)  
    MENTHOL, (+)- (UNII: C6B1OE8P3W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorPEPPERMINTImprint Code NONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74355-555-1110 in 1 PACKAGE; Type 0: Not a Combination Product04/01/2024
    2NDC:74355-555-12125 in 1 PACKAGE; Type 0: Not a Combination Product04/01/2024
    3NDC:74355-555-1310000 in 1 PACKAGE; Type 0: Not a Combination Product04/01/2024
    4NDC:74355-555-14380000 in 1 DRUM; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/01/2024
    Labeler - Avespan LLC (117415511)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spreewlder Arzneimittel GmbH332313084manufacture(74355-555)
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