Label: FLUORIDE- sodium fluoride tablet

  • NDC Code(s): 82149-001-01, 82149-001-02
  • Packager: Mintly Inc.
  • Category: HUMAN OTC DRUG LABEL

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 November 16, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.21% (0.30 mg fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Use

    Aids in the prevention of dental cavities

  • Warnings

    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: chew tablet briefly and 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 at 68-77°F (20-25°C).

    Protect from excessive moisture.

  • Inactive ingredients

    microcrystalline cellulose, sodium bicarbonate, silica, sodium lauroyl glutamate, magnesium stearate, natural mint flavor, menthol, xanthan gum, stevioside, citric acid

  • Questions?

    Call 888-478-6710

  • SPL UNCLASSIFIED SECTION

    DIST. BY MINTLY INC., PRINCETON, NJ 08540

  • PRINCIPAL DISPLAY PANEL - 240 Tablet Jar Label

    mintly

    TOOTHPASTE
    TABLETS

    with fluoride

    NATURAL MINT

    240
    TABLETS

    2.6 OZ (74.9g)

    Principal Display Panel - 240 Tablet Jar Label
  • INGREDIENTS AND APPEARANCE
    FLUORIDE 
    sodium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82149-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) Sodium Fluoride0.6552 mg
    Inactive Ingredients
    Ingredient NameStrength
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Sodium Lauroyl Glutamate (UNII: NCX1UU2D33)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Mint (UNII: FV98Z8GITP)  
    MENTHOL, (+)- (UNII: C6B1OE8P3W)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize9mm
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82149-001-0160 in 1 JAR; Type 0: Not a Combination Product08/30/2021
    2NDC:82149-001-02240 in 1 JAR; Type 0: Not a Combination Product08/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35508/30/2021
    Labeler - Mintly Inc. (118220595)
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