FDA.reportPublic FDA data

Mint Dentistry

Manufacturer
Nutrix Iternational, LLC. | Nutrix International, LLC.
Effective date
2022-05-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:32

Label at a glance#

ProductMint Dentistry
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and uses

Aids in the prevention of dental decay.

Dosage and administration

Adults and children 2 years and ove r: Brush teeth thoroughly after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age : Use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing). For C hildren under 2 years of age : Ask a dentist or doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24%
(0.15%w/v fluoride ion)

PURPOSE

OTC - PURPOSE SECTION

Anticavity

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay.

WARNING

WARNINGS SECTION

As with all fluoride toothpaste, keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

KEEP OUT OF REACH SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

Adults and children 2 years and over: Brush teeth thoroughly after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 6 years of age: Use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).

For C hildren under 2 years of age: Ask a dentist or doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Glycerin, Sorbitol, Hydrated Silicas, Water (Aqua), Xylitol, Cocamidopropyl Betaine, Mentha Piperita (Peppermint) Oil, Stevia Rebaudiana Leaf /Stem Extract, Xanthan Gum.

QUESTIONS?

OTC - QUESTIONS SECTION

Call 833.879.6468

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Use a pea-sized amount via oral

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonArtwork - Carton

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73333-120-012024-01-30C16284748780-1d6a99b39-be6c-a426-e053-dadaa90af4c2Mint Dentistry- Sexy Teeth
73333-120-012022-05-10C16284748780-1d6a99b39-be6c-a426-e053-dadaa90af4c2Mint Dentistry- Sexy Teeth
73333-120-012022-01-28C16284748780-1d6a99b39-be6c-a426-e053-dadaa90af4c2Mint Dentistry- Sexy Teeth

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73333-120-01Mint Dentistry113 g in 1 TUBEPASTE1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73333-120MINT DENTISTRY (MINT) PASTE [NUTRIX ITERNATIONAL, LLC.]3Legacy NDC, 1 package rows20220511_a3e94daa-b393-9a80-e053-2a95a90a0301.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73333-12073333-120-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
XYLITOLVCQ006KQ1EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT

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
deaed9d8-523d-6950-e053-2995a90a3c82a3e94daa-b393-9a80-e053-2a95a90a03012022-05-10WarningsExact identifier
spl id: deaed9d8-523d-6950-e053-2995a90a3c82
spl set id: a3e94daa-b393-9a80-e053-2a95a90a0301

Reported adverse events (FAERS/openFDA)#

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