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

  • 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 4, 2023

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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

    Bulk Label Mint 04

    120kg drum, NDC: 68984-122-04

  • INGREDIENTS AND APPEARANCE
    UNPASTE 
    zero waste fluoride mint tooth tabs tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68984-122
    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:68984-122-04380000 in 1 DRUM; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/10/2022
    Labeler - Farmina sp. z.o.o. (422254391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Farmina sp. z o.o., Zaklad w Myslenicach849477431manufacture(68984-122)
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