MIPASTE PLUS VANILLA paste, dentifrice

MIPaste Plus Vanilla by

Drug Labeling and Warnings

MIPaste Plus Vanilla by is a Otc medication manufactured, distributed, or labeled by GC America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Sodium fluoride 0.20% (w/w)

PURPOSE

Purpose
Anticavity

INDICATIONS & USAGE

Use
aids in the prevention
of dental cavities

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIPASTE PLUS VANILLA 
mipaste plus vanilla paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-802
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 g  in 100 g

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

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-802-10	10 in 1 BOX	02/03/2022
1	NDC: 61596-802-41	1 in 1 BOX, UNIT-DOSE
1	NDC: 61596-802-40	40 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological 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)

Registrant - GC America Inc. (005473608)

Establishment
Name	Address	ID/FEI	Business Operations
GC America Inc.		005473608	manufacture(61596-802)