Dentek Canker Cover

Manufacturer
Bershtel Enterprises
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:29:36

Label at a glance#

ProductDentek Canker Cover
Active ingredientMENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

menthol: 2.5 mg

Keep Out of Reach of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warning: Keep out of reach of children.

Purpose Section

OTC - PURPOSE SECTION

For Relief of pain associated with: canker sores & mouth sores.

Ask Doctor

OTC - ASK DOCTOR SECTION

Consult your dentist or doctor before using.

Indications & Usage

INDICATIONS & USAGE SECTION

Adult and Children 5 year of age and older.

The sore should be dry (pat with tissue) is 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 disolving. DO NOT REMOVE PATCH BEFORE IT DISSOLVES.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

2.5 mg per patch

Questions section

OTC - QUESTIONS SECTION

Call us 800-4Dentek (433-6835) M-F 8am - 5am EST or email us at Info@Dentek.com

Warning Section

WARNINGS SECTION

Keep out of reach of children. If irritation, pain, or redness worsens, if swelling, rash or fever develops, or if sore mouth systoms persists for 7 days, see your doctor or dentist.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  1. citrus medica fruit
  2. povidone
  3. colloidal silicon dioxide
  4. carbomer 934
  5. Xylitol
  6. Hydroxypropyl
  7. sea salt
  8. magnesium stearate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

consumer boxconsumer box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1725069menthol 2.5 MG Mucous Membrane Medicated PatchPSN10
1725069menthol 2.5 MG Medicated PatchSCD10
1725069menthol 2.5 MG Mucous Membrane Topical PatchSY10

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10564-0910-22024-12-13C16284748780-19d75b9d0-ed61-f424-e053-dadaa90a57ce2669183c-7a58-037e-e054-00144ff88e88
10564-0910-22020-01-31C16284748780-19d75b9d0-ed61-f424-e053-dadaa90a57ce2669183c-7a58-037e-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10564-0910-2Dentek Canker Cover1 in 1 CARTONPATCH, EXTENDED RELEASE110

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10564-091010564-0910-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Dentek Canker CoverMENTHOLBershtel Enterprises2669183c-7a58-037e-e054-00144ff88e882025-12-31WarningsExact identifier
ndc (package): 10564-0910-2
ndc (product): 10564-0910
ndc11 (package): 10564091002
spl id: 47419d1d-2da5-fed5-e063-6294a90a3d13
spl set id: 2669183c-7a58-037e-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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