Mint Fluoride Tooth

Manufacturer
Yangzhou SION Commodity Co.,Ltd
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:37

Label at a glance#

ProductMint Fluoride Tooth
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Indications and uses

aids in the prevention of cavities.

Dosage and administration

Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician Do not swallow To minimize wallowing, use a pea sizes amount in children under 6 years Supervise children's brushing

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE   0.243%(0.11 w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anti-cavity toothpaste

Uses

INDICATIONS & USAGE SECTION

aids in the prevention of cavities.

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age. If accidently swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.

Do not use if the inner foil is torn, cut, or missing

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician

Do not swallow

To minimize wallowing, use a pea sizes amount in children under 6 years

Supervise children's brushing

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated silica,Water, PEG-8, Sodium lauryl sulfate, Cellulose gum, Xanthan gum, flavor, Menthol, Dicalcium Phosphate, Methylparaben, Propylparaben, Titanium Dioxide, sodium sacharine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN3
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-011-02Mint Fluoride Tooth12 in 1 POUCHPASTE, DENTIFRICE123
70766-011-02Mint Fluoride Tooth12 in 1 BOXPASTE, DENTIFRICE123
70766-011-03Mint Fluoride Tooth12 in 1 POUCHPASTE, DENTIFRICE123
70766-011-03Mint Fluoride Tooth24 in 1 BOXPASTE, DENTIFRICE243
70766-011-04Mint Fluoride Tooth24 g in 1 TUBEPASTE, DENTIFRICE243
70766-011-04Mint Fluoride Tooth144 in 1 BOXPASTE, DENTIFRICE1443
70766-011-05Mint Fluoride Tooth24 g in 1 TUBEPASTE, DENTIFRICE243
70766-011-05Mint Fluoride Tooth288 in 1 BOXPASTE, DENTIFRICE2883
70766-011-06Mint Fluoride Tooth24 g in 1 TUBEPASTE, DENTIFRICE243
70766-011-06Mint Fluoride Tooth576 in 1 BOXPASTE, DENTIFRICE5763
70766-011-07Mint Fluoride Tooth12 in 1 POUCHPASTE, DENTIFRICE123
70766-011-07Mint Fluoride Tooth4 in 1 BOXPASTE, DENTIFRICE43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-011MINT FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [YANGZHOU SION COMMODITY CO.,LTD]3Legacy NDC, 12 package rows20231208_1fa163f3-6309-4bb3-85b8-6991d2eb758b.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70766-01170766-011-07, 70766-011-02, 70766-011-03, 70766-011-04, 70766-011-05, 70766-011-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
0bf9c776-573c-3f39-e063-6394a90a6d5c1fa163f3-6309-4bb3-85b8-6991d2eb758b2023-12-08WarningsExact identifier
spl id: 0bf9c776-573c-3f39-e063-6394a90a6d5c
spl set id: 1fa163f3-6309-4bb3-85b8-6991d2eb758b

Reported adverse events (FAERS/openFDA)#

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