MIPASTE ONE paste, dentifrice

MIPaste One by

Drug Labeling and Warnings

MIPaste One 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

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

INGREDIENTS AND APPEARANCE

MIPASTE ONE 
mipaste one paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-400
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-400-10	10 in 1 BOX	02/03/2022
1	NDC: 61596-400-41	1 in 1 BOX
1	NDC: 61596-400-40	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 Drug	M021	02/03/2022

Labeler - GC America Inc. (005473608)

Establishment
Name	Address	ID/FEI	Business Operations
GC America Inc.		005473608	manufacture(61596-400)