MIPaste One

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 01:27:26

Label at a glance#

ProductMIPaste One
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride

0.24% w/w

Potassium nitrate

5% (w/w)

INDICATIONS & USAGE SECTION

- aids in prevention of dental cavities

- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

WARNINGS SECTION

Warning If the sensitivity persists after 4 weeks of use, consult a dentist or physician. Keep out of reach of children. 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.

DOSAGE & ADMINISTRATION SECTION

For adults and children 12 years of age or older, apply a small, pea-size amount of MI Paste One to your toothbrush. For best results, brush for 2 minutes, expectorate and do not rinse; do not eat or drink for 30 minutes after brushing. Use twice daily. Replace cap after use. For children under 12 years of age, consult a dentist or physician.

INACTIVE INGREDIENT SECTION

Inactive ingredient Pure water, Glycerol, RECALDENT (CPP-ACP), Casein Phosphopeptide-Amorphous, Calcium Phosphate, Sorbitol, CMC-NA, Propylene glycol, Silicon dioxide, Titanium dioxide, Xylitol, Phosphoric acid, flavoring, Methyl salicylate, Sodium saccharin, Ethyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Butyl p-hydroxybenzoate, Sodium-N-lauroyl sarcosinate

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warning Keep out of reach of children.

OTC - PURPOSE SECTION

Anti-cavity

Anti-sensitivity

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN3
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD3
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61596-400-10MIPaste One10 in 1 BOXPASTE, DENTIFRICE103
61596-400-40MIPaste One46 g in 1 TUBEPASTE, DENTIFRICE463
61596-400-41MIPaste One1 in 1 BOXPASTE, DENTIFRICE13

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61596-40061596-400-40, 61596-400-41, 61596-400-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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 OneMIPASTE ONEGC America Inc.d71f8e6e-7005-4b3e-e053-2995a90a67892025-12-19WarningsExact identifier
ndc (package): 61596-400-40
ndc (package): 61596-400-10
ndc (package): 61596-400-41
ndc (product): 61596-400
ndc11 (package): 61596040010
ndc11 (package): 61596040040
ndc11 (package): 61596040041
spl id: 4651d664-464b-05c1-e063-6394a90a565e
spl set id: d71f8e6e-7005-4b3e-e053-2995a90a6789

Reported adverse events (FAERS/openFDA)#

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