MIPaste One Kids Cotton Candy

Manufacturer
GC America Inc.
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:27:24

Label at a glance#

ProductMIPaste One Kids Cotton Candy
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

INTENDED USE OF THE DEVICE

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DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

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 SECTION

Use
- aids in the prevention of dental
cavities

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - PURPOSE SECTION

Purpose: Anticavity

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Sodium Fluoride
0.24% w/w

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61596-102-01MIPaste One Kids Cotton Candy0.46 g in 1 TUBEPASTE, DENTIFRICE0.463
61596-102-02MIPaste One Kids Cotton Candy1 in 1 BOX, UNIT-DOSEPASTE, DENTIFRICE13
61596-102-10MIPaste One Kids Cotton Candy10 in 1 BOXPASTE, DENTIFRICE103

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61596-10261596-102-01, 61596-102-02, 61596-102-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIPaste One Kids Cotton CandyMIPASTE ONE KIDS COTTON CANDYGC America Inc.c07d6b50-1d67-ea7f-e053-2a95a90afbe42025-12-19WarningsExact identifier
ndc (package): 61596-102-01
ndc (package): 61596-102-10
ndc (package): 61596-102-02
ndc (product): 61596-102
ndc11 (package): 61596010210
ndc11 (package): 61596010201
ndc11 (package): 61596010202
spl id: 4651d522-2577-ae86-e063-6294a90a4dac
spl set id: c07d6b50-1d67-ea7f-e053-2a95a90afbe4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.