MIPASTE ONE- sodium fluoride, potassium nitrate 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

0.24% w/w Anti-cavity

Potassium nitrate

5% (w/w)* Anti-sensitivity

*Maximum FDA sensitivity active ingredient

Use

-aids in the prevention of dental cavities

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

Warning

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 and/or hydroxybenzoates allergy. In case of allergic reaction, stop use, rinse mouth with water and seek medical advice.

Directions

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

Inactive ingredient

Pure water, Glycerol, RECALDENT TM (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

Question or comments

1-708-323-7063 www.gcamerica.com

Warning

Keep out of reach of children.

PURPOSE

Anti-cavity toothpaste with bio-available calcium.

Anti-cavity

Rebuilds enamel

Helps against sensitivity

Sodium Fluoride 0.24% w/w (1,100ppmF)

Potassium Nitrate 5% w/w/

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INGREDIENTS AND APPEARANCE

MIPASTE  ONE
sodium fluoride, potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-437
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0024 g  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	0.06 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XYLITOL (UNII: VCQ006KQ1E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-437-41	1 in 1 BOX	07/03/2017
1	NDC: 61596-437-40	46 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/03/2017

Labeler - GC America Inc. (005473608)

Establishment
Name	Address	ID/FEI	Business Operations
GC America Inc.		005473608	manufacture(61596-437)