OTC - ACTIVE INGREDIENT SECTION
Triamcinolone Acetonide
ORAMEDY
- Manufacturer
- OASIS TRADING
- Effective date
- 2019-03-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:58:54
Label at a glance#
ProductORAMEDY
Active ingredientTRIAMCINOLONE ACETONIDE
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
For the treatment of chronic exfoliative gingivitis, obstinate stomatitis and glossitis with erosive and ulcerative lesions. For adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
INDICATIONS & USAGE SECTION
Apply a small dab to the lesion once to several times a day.
WARNINGS SECTION
For external use only.
Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator.
Ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash.
When using this product consult a doctor before exceeding recommended dosage.
Stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
INACTIVE INGREDIENT SECTION
Sodium Carboxymethyl Cellulose, Sodium Polyacrylate, Pectin, Plastibase
DOSAGE & ADMINISTRATION SECTION
For buccal use only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| TRIAMCINOLONE ACETONIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d4d7da1a-7fd4-628e-cdae-89e749b1c534 | Product name | 7 | 20260127 |
| 75f7e47b-8736-a182-fc44-22aca8d79689 | Product name | 2 | 20251211 |
| 62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2 | Product name | 6 | 20250516 |
| e42f429b-c4e5-0402-e1c5-730154df4060 | Product name | 4 | 20240205 |
| 38d4de13-64b3-4057-b91c-4b5126962341 | Product name | 1 | 20220516 |
| 089e0644-1ea8-8654-4113-39f960dd57d5 | Product name | 3 | 20210115 |
| 1629e00f-54fb-4a43-8306-b58442b23902 | Product name | 9 | 20200430 |
| 5331c9c8-f64b-11e6-ccf1-071c477fcb0b | Product name | 7 | 20190612 |
| 9f64e0dc-109c-9660-8e0e-91ec987b3817 | Product name | 6 | 20171204 |
| dfa879a3-32de-49f0-a7ba-9b9c3e13002f | Product name | 1 | 20171204 |
| 8de20f81-8411-4cf1-a8b2-03404ee56d01 | Product name | 3 | 20171109 |
| a5f1a68c-0352-4f34-46a3-9b4eed239ed8 | Product name | 2 | 20160819 |
| 355b2224-0895-7135-83f5-d099a6a82a0a | Product name | 1 | 20140508 |
| 55be6b50-8cc0-f0f1-74a1-3416a91193aa | Product name | 1 | 20140508 |
| 7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cf | Product name | 1 | 20140508 |
| 89b93c13-4be8-69f3-b33b-63e64feffb9b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72689-0039-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2fee-a910-e053-dadaa90a0b85 | 846c56c9-e8ef-02f5-e053-2a91aa0a835f |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72689-0039-1 | ORAMEDY | 10 g in 1 TUBE | OINTMENT | 10 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72689-0039 | ORAMEDY (TRIAMCINOLONE ACETONIDE) OINTMENT [OASIS TRADING] | 1 | Legacy NDC, 1 package rows | 20190320_846c56c9-e8ef-02f5-e053-2a91aa0a835f.zip |
Products#
Every source-derived product name is available through these pages.
- ORAMEDY
- Triamcinolone Acetonide
- SODIUM POLYACRYLATE (2500000 MW)
- PECTIN
- CARBOXYMETHYLCELLULOSE SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72689-0039 | 72689-0039-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM POLYACRYLATE (2500000 MW) | 05I15JNI2J | IACT |
| PECTIN | 89NA02M4RX | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| TRIAMCINOLONE ACETONIDE | F446C597KA | 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 |
|---|---|---|---|---|---|---|
| 846c196a-5b5c-08d4-e053-2991aa0a4d85 | 846c56c9-e8ef-02f5-e053-2a91aa0a835f | 2019-03-19 | Warnings | 846c196a-5b5c-08d4-e053-2991aa0a4d85 846c56c9-e8ef-02f5-e053-2a91aa0a835f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.