DenTek Canker Cover
- Manufacturer
- DenTek Oral Care, Inc.
- Effective date
- 2015-12-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 22:44:19
Label at a glance#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient: (per each patch)
Menthol 2.5 mg
OTC - PURPOSE SECTION
Purpose
Oral Pain Reliever
INDICATIONS & USAGE SECTION
Uses: for the relief of pain associated with: . canker sores . mouth sores
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Warnings:
Keep out of reach of children.
WARNINGS SECTION
Warnings:
If irritation, pain or redness worsens, if swelling, rash or fever develops, or if sore mouth symptoms persist
for 7 days, see your doctor or dentist.
DOSAGE & ADMINISTRATION SECTION
Directions for use:adults and children 5 years of age and older
The sore should be dry (pat with tissue) if possible. Place the Canker Cover Patch on a
clean, dry finger with the white side up. Place the white side on the sore and hold in place
for 20 seconds. Within 30 minutes the tablet forms a clear, gel-like bandage that seals and protects the sore
for hours before dissolving. Do not remove the patch before it dissolves. Consult your dentist or doctor before using.
In case of discomfort, the patch may be removed by gently peeling it from the sides with your finger while
washing with warm water.
INACTIVE INGREDIENT SECTION
Inactive ingredients: carbomer homopolymer type a, polyvinyl pyrrolidone, xylitol, hydroxypropyl cellulose, silicon dioxide, carmallite TM(mineral salt), citrus oil, annatto.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1725075 | CankerCover 2.5 MG Mucous Membrane Medicated Patch | PSN | 4 |
| 1725069 | menthol 2.5 MG Mucous Membrane Medicated Patch | PSN | 4 |
| 1725075 | menthol 2.5 MG Medicated Patch [Canker Cover] | SBD | 4 |
| 1725069 | menthol 2.5 MG Medicated Patch | SCD | 4 |
| 1725075 | Canker Cover 2.5 MG Medicated Patch | SY | 4 |
| 1725075 | Canker Cover 2.5 MG Mucous Membrane Topical Patch | SY | 4 |
| 1725069 | menthol 2.5 MG Mucous Membrane Topical Patch | SY | 4 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 60630-091-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2650-f424-e053-dadaa90a57ce | Canker Cover 1 Count |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60630-091-01 | DenTek Canker Cover | 2.5 mg in 1 DOSE PACK | PATCH, EXTENDED RELEASE | 2.5 | 4 | |
| 60630-091-04 | DenTek Canker Cover | 1 in 1 PACKET | PATCH, EXTENDED RELEASE | 1 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- DenTek Canker Cover
- Menthol
- SEA SALT
- CARBOMER 934
- POVIDONE
- XYLITOL
- HYDROXYPROPYL CELLULOSE (TYPE E)
- CITRUS MEDICA FRUIT
- COLLOIDAL SILICON DIOXIDE
- MAGNESIUM STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60630-091 | 60630-091-01, 60630-091-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SEA SALT | 87GE52P74G | IACT |
| CARBOMER 934 | Z135WT9208 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| HYDROXYPROPYL CELLULOSE (TYPE E) | 66O7AQV0RT | IACT |
| CITRUS MEDICA FRUIT | ZE5Q6PN9ON | IACT |
| COLLOIDAL SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MENTHOL | L7T10EIP3A | 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 |
|---|---|---|---|---|---|---|
| 26921ec2-016d-331e-e054-00144ff88e88 | 25de07eb-8232-6663-e054-00144ff88e88 | 2015-12-10 | Warnings | 26921ec2-016d-331e-e054-00144ff88e88 25de07eb-8232-6663-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
