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

MIPaste by

Drug Labeling and Warnings

MIPaste by is a Otc medication manufactured, distributed, or labeled by GC America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-986
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2 g  in 0.2 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-986-41	1 in 1 BOX	06/01/2015
1	NDC: 61596-986-40	40 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/01/2015

MIPASTE  PLUS
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-884
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2 g  in 0.2 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-884-41	1 in 1 BOX	06/01/2015
1	NDC: 61596-884-40	40 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/01/2015

MIPASTE  PLUS
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-888
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2 g  in 0.2 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-888-41	1 in 1 BOX	06/01/2015
1	NDC: 61596-888-40	40 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/01/2015

MIPASTE  PLUS
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-880
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2 g  in 0.2 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-880-41	1 in 1 BOX	06/01/2015
1	NDC: 61596-880-40	40 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/01/2015

MIPASTE  PLUS
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-882
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2 g  in 0.2 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-882-41	1 in 1 BOX	06/01/2015
1	NDC: 61596-882-40	40 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/01/2015

Labeler - GC America Inc. (005473608)

Registrant - GC America Inc. (005473608)

Establishment
Name	Address	ID/FEI	Business Operations
GC America Inc.		005473608	manufacture(61596-986, 61596-884, 61596-888, 61596-880, 61596-882)