MIPASTE ONE- mipaste one paste, dentifrice 
GC America Inc.

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Sodium fluoride

0.24% w/w

Potassium nitrate

5% (w/w)

- aids in prevention of dental cavities

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

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.

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 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

Warning Keep out of reach of children.

Anti-cavity

Anti-sensitivity

Box

MIPASTE ONE 
mipaste one paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61596-400
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61596-400-1010 in 1 BOX02/03/2022
1NDC:61596-400-411 in 1 BOX
1NDC:61596-400-4046 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02102/03/2022
Labeler - GC America Inc. (005473608)
Establishment
NameAddressID/FEIBusiness Operations
GC America Inc.005473608manufacture(61596-400)

Revised: 1/2024
Document Id: 0feb733e-a4e8-20f5-e063-6294a90a882d
Set id: d71f8e6e-7005-4b3e-e053-2995a90a6789
Version: 2
Effective Time: 20240127
 
GC America Inc.