MIPASTE PLUS STRAWBERRY- sodium fluoride paste, dentifrice 
MIPASTE PLUS- sodium fluoride paste, dentifrice 
GC America Inc.

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.

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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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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)

Revised: 1/2020
Document Id: 9c95f1b6-c9f7-7f4c-e053-2a95a90a36db
Set id: 1b68bd67-65d3-4c64-e054-00144ff8d46c
Version: 7
Effective Time: 20200120
 
GC America Inc.