FDA.reportPublic FDA data

DenTek Canker Cover

Manufacturer
DenTek Oral Care, Inc.
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:46:45

Label at a glance#

ProductDenTek Canker Cover
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

for the temporary relief of pain associated with:  canker sores mouth sores minor irritation of the mouth and gums.

Dosage and administration

adults and children 5 years of age and older, apply up to 3 times a day, as needed The sore should be dry (pat with tissue) if possible. Place the 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. If sore is difficult to reach (in the fold between the cheek and gum or near the teeth or lip) break the patch along the score and use half. Some disc...

Label contents#

Full prescribing information#

Active ingredient(per each patch)

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.5 mg

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain associated with: 

  • canker sores
  • mouth sores
  • minor irritation of the mouth and gums.

Warnings

WARNINGS SECTION

Stop use and ask a dentist or doctor if

OTC - ASK DOCTOR SECTION

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness worsens
  • swelling, rash or fever develops

If pregnant or breast-feeding or taking prescription drugs,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 5 years of age and older,apply up to 3 times a day, as needed
    The sore should be dry (pat with tissue) if possible. Place the 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. If sore is difficult to reach (in the fold between the cheek and gum or near the teeth or lip) break the patch along the score and use half. Some discomfort may occur during the first few minutes, but will quickly subside, followed by hours of soothing relief. 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.  In case of discomfort, the patch may be removed by gently peeling the tablet from the sides while washing with warm water. Do not use any instrument to remove the patch.  
  • children under 5 years, ask a doctor

Other information

SPL UNCLASSIFIED SECTION

store in a cool dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

annatto, carbomer homopolymer type a, flavor, hydroxypropyl cellulose, potassium magnesium chloride hydrate, povidone K30, povidone K90, silicon dioxide, xylitol

Questions

OTC - QUESTIONS SECTION

800-4DENTEK (433-6835)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DenTek
CANKER COVER
CANKER SORE PATCH
6 COUNT

DenTek CANKER COVER CANKER SORE PATCH 6 COUNTDenTek CANKER COVER CANKER SORE PATCH 6 COUNT

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60630-091-022024-12-13C16284748780-19d75b9d0-7f27-f424-e053-dadaa90a57ceDenTek Canker Cover 60630-091
60630-091-022020-01-31C16284748780-19d75b9d0-7f27-f424-e053-dadaa90a57ceDenTek Canker Cover 60630-091

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60630-091DENTEK CANKER COVER (MENTHOL) PATCH, EXTENDED RELEASE [DENTEK ORAL CARE, INC.]5Legacy NDC20241215_dccdb4ef-203f-4c9b-85b4-a8a061c5656d.zip

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
60630-09160630-091-01, 60630-091-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANNATTO6PQP1V1B6OIACT
CARBOMER HOMOPOLYMER TYPE AF68VH75CJCIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POVIDONE K30U725QWY32XIACT
POVIDONE K90RDH86HJV5ZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XYLITOLVCQ006KQ1EIACT
MENTHOLL7T10EIP3AACTIB

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
9db79bec-3ba5-47dd-a001-ce7a4a7aec1adccdb4ef-203f-4c9b-85b4-a8a061c5656d2025-11-19WarningsExact identifier
spl set id: dccdb4ef-203f-4c9b-85b4-a8a061c5656d

Reported adverse events (FAERS/openFDA)#

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