MIPaste

Manufacturer
GC America Inc.
Effective date
2020-10-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:31:31

Label at a glance#

ProductMIPaste ONE
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride

0.24% w/w Anti-cavity

Potassium nitrate

5% (w/w)* Anti-sensitivity

*Maximum FDA sensitivity active ingredient

Use

INDICATIONS & USAGE SECTION

-aids in the prevention of dental cavities

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

Warning

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 and/or hydroxybenzoates allergy. In case of allergic reaction, stop use, rinse mouth with water and seek medical advice.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredient

INACTIVE INGREDIENT SECTION

Pure water, Glycerol, RECALDENT TM (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

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Anti-cavity toothpaste with bio-available calcium.

Anti-cavity

Rebuilds enamel

Helps against sensitivity

Sodium Fluoride 0.24% w/w (1,100ppmF)

Potassium Nitrate 5% w/w/

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61596-437-412022-01-28C16284748780-1d6a99b39-e3a8-a426-e053-dadaa90af4c24d63020f-934c-2af4-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61596-437-40MIPasteONE46 g in 1 TUBEPASTE, DENTIFRICE465
61596-437-41MIPasteONE1 in 1 BOXPASTE, DENTIFRICE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61596-437MIPASTE ONE (SODIUM FLUORIDE, POTASSIUM NITRATE) PASTE, DENTIFRICE [GC AMERICA INC.]5Legacy NDC, 2 package rows20201014_4d63020f-934c-2af4-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61596-43761596-437-40, 61596-437-41

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 · Source PDF

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
b192ae37-ad33-5e68-e053-2a95a90a14434d63020f-934c-2af4-e054-00144ff8d46c2020-10-13WarningsExact identifier
spl id: b192ae37-ad33-5e68-e053-2a95a90a1443
spl set id: 4d63020f-934c-2af4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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