OTC - ACTIVE INGREDIENT SECTION
Tricalcium Phosphate, Dental Type Silica (Silicon Dioxide), Tocopheryl Acetate (.ALPHA.-TOCOPHEROL ACETATE)
DIO Enamel Coating Pen Pro Tooth
- Manufacturer
- Dio Corporation | KMPharmaceutical Co., Ltd.
- Effective date
- 2017-06-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:50:02
Label at a glance#
ProductDIO Enamel Coating Pen Pro Tooth
Active ingredientTRICALCIUM PHOSPHATE, .ALPHA.-TOCOPHEROL ACETATE, SILICON DIOXIDE
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
For dental care
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
INDICATIONS & USAGE SECTION
- Spin the lever at the bottom of the product clockwise
- Rub the silicon tip smoothly on the sensitive area (60 seconds)
- Rinse your mouth after 30 seconds once the product is absorbed)
WARNINGS SECTION
Alright container, store at room temperature (1-30)
INACTIVE INGREDIENT SECTION
Sorbitol, water, etc.
DOSAGE & ADMINISTRATION SECTION
For dental use only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bee4fa8d-8d82-423a-a0b5-40a89dd13a99 | Product name | 1 | 20250618 |
| e0d2eb29-08bd-4bba-90d1-c91c68a38767 | Product name | 4 | 20250516 |
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 334fe8d2-68fb-4331-a576-420e302ec069 | Product name | 7 | 20240320 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| e92765c1-be81-432a-b909-1b10777ec378 | Product name | 1 | 20190208 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 0441a8f5-3835-497c-aedd-bc78cba56b2a | Product name | 1 | 20150317 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75902-6001-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-82ff-f424-e053-dadaa90a57ce | 413ab9ba-7930-0f0d-e054-00144ff8d46c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75902-6001-1 | DIO Enamel Coating Pen Pro Tooth | 5 g in 1 BOTTLE, WITH APPLICATOR | PASTE, DENTIFRICE | 5 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 75902-6001 | DIO ENAMEL COATING PEN PRO TOOTH (TRICALCIUM PHOSPHATE, DENTAL TYPE SILICA, TOCOPHERYL ACETATE) PASTE, DENTIFRICE [DIO CORPORATION] | 2 | Legacy NDC, 1 package rows | 20170605_413ab9ba-7930-0f0d-e054-00144ff8d46c.zip |
Products#
Every source-derived product name is available through these pages.
- DIO Enamel Coating Pen Pro Tooth
- Tricalcium Phosphate, Dental Type Silica, Tocopheryl Acetate
- SORBITOL
- WATER
- TRICALCIUM PHOSPHATE
- CALCIUM CATION
- .ALPHA.-TOCOPHEROL ACETATE
- .ALPHA.-TOCOPHEROL
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75902-6001 | 75902-6001-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| TRICALCIUM PHOSPHATE | K4C08XP666 | ACTIM |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 50e23c08-72fb-6d1a-e054-00144ff8d46c | 413ab9ba-7930-0f0d-e054-00144ff8d46c | 2017-06-01 | Warnings | 50e23c08-72fb-6d1a-e054-00144ff8d46c 413ab9ba-7930-0f0d-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.