MIPaste One Kids Bubble Gum
- 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 01:27:23
Label at a glance#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Sodium Fluoride
0.24% w/w
OTC - PURPOSE SECTION
Anti-cavity
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
Anti-cavity toothpaste with bio-available
calcium, phosphate and Fluoride
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 416783 | sodium fluoride 0.24 % Toothpaste | PSN | 3 |
| 416783 | sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 3 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste | SY | 3 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 3 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 3 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61596-101-01 | MIPaste One Kids Bubble Gum | 46 g in 1 TUBE | PASTE, DENTIFRICE | 46 | 3 | |
| 61596-101-02 | MIPaste One Kids Bubble Gum | 1 in 1 BOX, UNIT-DOSE | PASTE, DENTIFRICE | 1 | 3 | |
| 61596-101-10 | MIPaste One Kids Bubble Gum | 10 in 1 BOX | PASTE, DENTIFRICE | 10 | 3 |
Products#
Every source-derived product name is available through these pages.
- MIPaste One Kids Bubble Gum
- WATER
- SILICON DIOXIDE
- BUTYLPARABEN
- SORBITOL
- PROPYLENE GLYCOL
- PHOSPHORIC ACID
- PROPYLPARABEN
- GLYCERIN
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- TITANIUM DIOXIDE
- ETHYLPARABEN
- XYLITOL
- SODIUM LAUROYL SARCOSINATE
- SACCHARIN SODIUM
- CALCIUM PHOSPHATE, UNSPECIFIED FORM
- SODIUM FLUORIDE
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61596-101 | 61596-101-01, 61596-101-02, 61596-101-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MIPaste One Kids Bubble Gum | MIPASTE ONE KIDS BUBBLE GUM | GC America Inc. | c07c7853-763b-4383-e053-2995a90ab725 | 2025-12-19 | Warnings | 61596-101-10 61596-101-01 61596-101-02 61596-101 61596010110 61596010101 61596010102 4651d664-464a-05c1-e063-6394a90a565e c07c7853-763b-4383-e053-2995a90ab725 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

