MIPASTE ONE- sodium fluoride, potassium nitrate 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

0.24% 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.

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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MIPASTE  ONE
sodium fluoride, potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61596-437
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0024 g  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61596-437-411 in 1 BOX07/03/2017
1NDC:61596-437-4046 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/03/2017
Labeler - GC America Inc. (005473608)
Establishment
NameAddressID/FEIBusiness Operations
GC America Inc.005473608manufacture(61596-437)

Revised: 10/2020
Document Id: b192ae37-ad33-5e68-e053-2a95a90a1443
Set id: 4d63020f-934c-2af4-e054-00144ff8d46c
Version: 5
Effective Time: 20201013
 
GC America Inc.