MIPASTE ONE KIDS COTTON CANDY paste, dentifrice

MIPaste One Kids Cotton Candy by

Drug Labeling and Warnings

MIPaste One Kids Cotton Candy 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

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

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.

PURPOSE

Purpose: Anticavity

ACTIVE INGREDIENT

Active ingredient
Sodium Fluoride
0.24% w/w

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIPASTE ONE KIDS COTTON CANDY 
mipaste one kids cotton candy paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61596-102
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
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETHYLPARABEN (UNII: 14255EXE39)
CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61596-102-10	10 in 1 BOX	04/21/2021
1	NDC: 61596-102-02	1 in 1 BOX, UNIT-DOSE
1	NDC: 61596-102-01	0.46 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(61596-102)