Label: MIPASTE ONE paste, dentifrice

  • NDC Code(s): 61596-400-10, 61596-400-40, 61596-400-41
  • Packager: GC America Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 27, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Sodium fluoride

    0.24% w/w

    Potassium nitrate

    5% (w/w)

  • INDICATIONS & USAGE

    - aids in prevention of dental cavities

    - builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

  • WARNINGS

    Warning If the sensitivity persists after 4 weeks of use, consult a dentist or physician. Keep out of reach of children. If more than the recommended amount of paste used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use on patients with a milk protein or hydroxybenzoates allergy. In case of allergic reaction, stop use, rinse mouth with water and seek medical advice.

  • DOSAGE & ADMINISTRATION

    For adults and children 12 years of age or older, apply a small, pea-size amount of MI Paste One to your toothbrush. For best results, brush for 2 minutes, expectorate and do not rinse; do not eat or drink for 30 minutes after brushing. Use twice daily. Replace cap after use. For children under 12 years of age, consult a dentist or physician.

  • INACTIVE INGREDIENT

    Inactive ingredient Pure water, Glycerol, RECALDENT (CPP-ACP), Casein Phosphopeptide-Amorphous, Calcium Phosphate, Sorbitol, CMC-NA, Propylene glycol, Silicon dioxide, Titanium dioxide, Xylitol, Phosphoric acid, flavoring, Methyl salicylate, Sodium saccharin, Ethyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Butyl p-hydroxybenzoate, Sodium-N-lauroyl sarcosinate

  • KEEP OUT OF REACH OF CHILDREN

    Warning Keep out of reach of children.

  • PURPOSE

    Anti-cavity

    Anti-sensitivity

  • PRINCIPAL DISPLAY PANEL

    Box

  • INGREDIENTS AND APPEARANCE
    MIPASTE ONE 
    mipaste one paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61596-400
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61596-400-1010 in 1 BOX02/03/2022
    1NDC:61596-400-411 in 1 BOX
    1NDC:61596-400-4046 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/03/2022
    Labeler - GC America Inc. (005473608)
    Establishment
    NameAddressID/FEIBusiness Operations
    GC America Inc.005473608manufacture(61596-400)