Label: MINT DENTISTRY- mint paste

  • 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 10, 2022

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  • ACTIVE INGREDIENT

    Sodium fluoride 0.24%
    (0.15%w/v fluoride ion)

  • PURPOSE

    Anticavity

  • INDICATIONS AND USAGE

    Aids in the prevention of dental decay.

  • WARNING

    As with all fluoride toothpaste, keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

  • KEEP OUT OF REACH SECTION

    Keep out of reach of children under 6 years of age.

  • DIRECTIONS

    Adults and children 2 years and over: Brush teeth thoroughly after each meal or at least twice a day, or as directed by a dentist or doctor.
    Children under 6 years of age: Use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).

    For C hildren under 2 years of age: Ask a dentist or doctor.

  • INACTIVE INGREDIENTS

    Glycerin, Sorbitol, Hydrated Silicas, Water (Aqua), Xylitol, Cocamidopropyl Betaine, Mentha Piperita (Peppermint) Oil, Stevia Rebaudiana Leaf /Stem Extract, Xanthan Gum.

  • QUESTIONS?

    Call 833.879.6468

  • Dosage and Administration

    Use a pea-sized amount via oral

  • Package

    Carton Artwork - Carton

  • INGREDIENTS AND APPEARANCE
    MINT DENTISTRY 
    mint paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73333-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2938 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R) 24.86 g  in 113 g
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) 0.1695 g  in 113 g
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1.8532 g  in 113 g
    XANTHAN GUM (UNII: TTV12P4NEE) 0.452 g  in 113 g
    GLYCERIN (UNII: PDC6A3C0OX) 31.753 g  in 113 g
    XYLITOL (UNII: VCQ006KQ1E) 11.3 g  in 113 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 23.73 g  in 113 g
    PEPPERMINT OIL (UNII: AV092KU4JH) 0.339 g  in 113 g
    WATER (UNII: 059QF0KO0R) 18.2495 g  in 113 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73333-120-01113 g in 1 TUBE; Type 0: Not a Combination Product04/22/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/22/2020
    Labeler - Nutrix Iternational, LLC. (117341868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutrix International, LLC.117341868manufacture(73333-120) , pack(73333-120) , label(73333-120)
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