MIPASTE ONE KIDS BUBBLE GUM paste, dentifrice

MIPaste One Kids Bubble Gum by

Drug Labeling and Warnings

MIPaste One Kids Bubble Gum by is a Otc medication manufactured, distributed, or labeled by GC America Inc., GC America Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INTENDED USE OF THE DEVICE

ACTIVE INGREDIENT

Active ingredient
Sodium Fluoride
0.24% w/w

PURPOSE

Anti-cavity

DOSAGE & ADMINISTRATION

Directions For adults and children 2
years of age or older, apply a small,
pea-size amount of MI Paste ONE
Kids to your toothbrush. For best
results, brush for 2 minutes,
expectorate and avoid eating or
drinking for 30 minutes after brushing.
Use twice daily. Replace cap after
use. For children under 2 years of age,
consult a dentist or physician.

WARNINGS

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

INACTIVE INGREDIENT

Inactive ingredients Pure water,
Glycerol, RECALDENT CPP-ACP
Casein Phosphopeptide-Amorphous
Calcium Phosphate, Sorbitol,
CMC-Na, Propylene glycol, Silicon
dioxide, Titanium dioxide, Xylitol,
Phosphoric acid, Flavoring, Sodium
saccharin, Ethyl p-hydroxybenzoate,
Propyl p-hydroxybenzoate, Butyl
p-hydroxybenzoate, Sodium-N-lauroyl
sarcosinate.

INDICATIONS & USAGE

Use
- aids in the prevention of dental
cavities

Anti-cavity toothpaste with bio-available
calcium, phosphate and Fluoride

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIPASTE ONE KIDS BUBBLE GUM 
mipaste one kids bubble gum paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-101
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHOSPHORIC ACID (UNII: E4GA8884NN)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETHYLPARABEN (UNII: 14255EXE39)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-101-10	10 in 1 BOX	04/21/2021
1	NDC: 61596-101-02	1 in 1 BOX, UNIT-DOSE
1	NDC: 61596-101-01	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	04/21/2021

Labeler - GC America Inc. (005473608)

Establishment
Name	Address	ID/FEI	Business Operations
GC America Inc.		005473608	manufacture(61596-101)