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#

ProductDenTek Canker Cover
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

Outer Packet Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Canker Cover 1 Count PacketCanker Cover 1 Count Packet

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 table
RxCUIRxNorm stringTTYSPL version
1725075CankerCover 2.5 MG Mucous Membrane Medicated PatchPSN4
1725069menthol 2.5 MG Mucous Membrane Medicated PatchPSN4
1725075menthol 2.5 MG Medicated Patch [Canker Cover]SBD4
1725069menthol 2.5 MG Medicated PatchSCD4
1725075Canker Cover 2.5 MG Medicated PatchSY4
1725075Canker Cover 2.5 MG Mucous Membrane Topical PatchSY4
1725069menthol 2.5 MG Mucous Membrane Topical PatchSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60630-091-042020-01-31C16284748780-19d75b9d0-2650-f424-e053-dadaa90a57ceCanker Cover 1 Count

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60630-091-01DenTek Canker Cover2.5 mg in 1 DOSE PACKPATCH, EXTENDED RELEASE2.54
60630-091-04DenTek Canker Cover1 in 1 PACKETPATCH, EXTENDED RELEASE14

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.]4Legacy NDC, 2 package rows20151211_25de07eb-8232-6663-e054-00144ff88e88.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, 60630-091-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
26921ec2-016d-331e-e054-00144ff88e8825de07eb-8232-6663-e054-00144ff88e882015-12-10WarningsExact identifier
spl id: 26921ec2-016d-331e-e054-00144ff88e88
spl set id: 25de07eb-8232-6663-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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