Label: MIPASTE PLUS STRAWBERRY- sodium fluoride paste, dentifrice
MIPASTE PLUS- sodium fluoride paste, dentifrice

  • NDC Code(s): 61596-880-40, 61596-880-41, 61596-882-40, 61596-882-41, view more
    61596-884-40, 61596-884-41, 61596-888-40, 61596-888-41, 61596-986-40, 61596-986-41
  • Packager: GC America Inc.
  • 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 January 20, 2020

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  • Active Ingredient

    Sodium Fluoride 0.2% (w/w)............Anticavity

  • Use

    Aids in the prevention of dental cavities

  • Warnings

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

  • Warnings

    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. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

  • Directions

    * Adults and children over 12: brush teeth with your normal toothpaste at least twice a day, or as directed by your dental profession or doctor, rinse mouth after brushing, dispense a pea-sized portion of MI Paste Plus onto your finger, apply thoroughly, coating the upper teeth with an even layer, repeat for lower teeth, allow to remain on teeth for 3 mintues. Do not rinse.

    * Children under the age of 12: consult your dental professional or doctor.

  • Other information

    For additional application instructions, refer to the product insert.

  • Inactive ingredients

    Butyl p-hydroxybenzoate, Casein phosphopeptides and amorphous calcium phosphate, D-sorbitol, Ethyl p-hydroxybenzoate, Flavoring, Glycerol, Phosphoric acid, Propyl p-hydroxybenzoate, Propylene glycol, Silicon dioxide, sodium carboxymethyl cellulose, Sodium saccharin, Titanium dioxide, Water, Xylitol

  • Questions or comments?

    1-800-323-7063

  • Recommended Indications

    To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. Secondarily, MI Paste Plus can be used for the management of tooth sensitivity, post-scaling, root planing and bleaching.

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  • INGREDIENTS AND APPEARANCE
    MIPASTE PLUS STRAWBERRY 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61596-986
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XYLITOL (UNII: VCQ006KQ1E)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61596-986-411 in 1 BOX06/01/2015
    1NDC:61596-986-4040 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2015
    MIPASTE  PLUS
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61596-884
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61596-884-411 in 1 BOX06/01/2015
    1NDC:61596-884-4040 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2015
    MIPASTE  PLUS
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61596-888
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61596-888-411 in 1 BOX06/01/2015
    1NDC:61596-888-4040 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2015
    MIPASTE  PLUS
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61596-880
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorTUTTI FRUTTIImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61596-880-411 in 1 BOX06/01/2015
    1NDC:61596-880-4040 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2015
    MIPASTE  PLUS
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61596-882
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XYLITOL (UNII: VCQ006KQ1E)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61596-882-411 in 1 BOX06/01/2015
    1NDC:61596-882-4040 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2015
    Labeler - GC America Inc. (005473608)
    Registrant - GC America Inc. (005473608)
    Establishment
    NameAddressID/FEIBusiness Operations
    GC America Inc.005473608manufacture(61596-986, 61596-884, 61596-888, 61596-880, 61596-882)
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