ONETOOTH CLINIC TOOTH

Manufacturer
CONE MEDICAL Co., Ltd.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:29:40

Label at a glance#

ProductONETOOTH CLINIC TOOTH
Active ingredientSODIUM PYROPHOSPHATE, SILICON DIOXIDE, ALPHA-TOCOPHEROL ACETATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate

OTC - PURPOSE SECTION

For dental health

For dental care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Brushing the teeth with a suitable amount

WARNINGS SECTION

  • Do not swallow and rinse mouth thoroughly after use
  • If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.
  • For children under 6 years of age, use small amounts of toothpaste. And
  • use itunder the supervision of a guardian to avoid sucking or swallowing.
  • Consult a physician or dentist immediately if a child under 6 years old
  • hasswallowed large quantities.
  • Keep out of the reach of children under 6 years of age.

INACTIVE INGREDIENT SECTION

D-Sorbitol Solution, Concentrated Glycerin, Carboxymethylcellulose Sodium, Hydroxyapatite, Medicinal Carbon, Chitosan, Titanium Oxide and Mica, Zeolite, Xylitol, Steviol Glycoside, Papain, Grapefruit Seed Extract, L-Menthol, Mentha Oil, Propolis Extract, Chamomile Extract, Rosemary Extract, Sage Extract, Aloe Extract, Glycyrrhiza Extract, Lavender Oil, Horsetail Extract, Sodium Cocoyl Glutamate, Lauroyl Amidopropyl Dimethyl Glycine Solution, Deionized Water

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73527-0002-12023-11-30C16284748780-10191ceaa-6fab-198a-e063-dbdaa90aec3ebd50abcd-8a85-2923-e053-2995a90a109b
73527-0002-12023-07-28C16284748780-10191ceaa-6fab-198a-e063-dbdaa90aec3ebd50abcd-8a85-2923-e053-2995a90a109b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73527-0002-1ONETOOTH CLINIC TOOTH20 g in 1 TUBEPASTE205

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73527-000273527-0002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
ONETOOTH CLINIC TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.bd50abcd-8a85-2923-e053-2995a90a109b2025-12-30WarningsExact identifier
ndc (package): 73527-0002-1
ndc (product): 73527-0002
ndc11 (package): 73527000201
spl id: 4736f8ae-d1bb-037d-e063-6394a90a9ddb
spl set id: bd50abcd-8a85-2923-e053-2995a90a109b

Reported adverse events (FAERS/openFDA)#

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