MIPASTE PLUS MELON- mipaste plus melon paste, dentifrice 
GC America Inc.

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Active Ingredient
Sodium fluoride 0.20% (w/w)

Purpose
Anticavity

Use
• aids in the prevention
of dental cavities

Warnings
Keep out of reach of children under 6 years of age.
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.

Warnings
Keep out of reach of children under 6 years of age.

Directions
• adults and children over 12:
brush teeth with your normal
toothpaste at least twice a day, or
as directed by your dental
professional 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
minutes. Do not rinse.
• children under the age of 12:
consult your dental professional or
doctor

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

Box

MIPASTE PLUS MELON 
mipaste plus melon paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61596-804
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61596-804-1010 in 1 BOX02/03/2022
1NDC:61596-804-411 in 1 BOX, UNIT-DOSE
1NDC:61596-804-4040 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02102/03/2022
Labeler - GC America Inc. (005473608)
Registrant - GC America Inc. (005473608)
Establishment
NameAddressID/FEIBusiness Operations
GC America Inc.005473608manufacture(61596-804)

Revised: 1/2024
Document Id: 0feb8ce1-4aad-2b13-e063-6294a90a633e
Set id: d724fe9f-c9ef-d9ad-e053-2995a90a7ecf
Version: 2
Effective Time: 20240127
 
GC America Inc.