Active Ingredient
menthol: 2.5 mg
Dentek Canker Cover Patch, Extended Release
FDA Label NDC 10564-0910
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bershtel Enterprises for the product Dentek Canker Cover (NDC 10564-0910). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, keep out of reach of children section, purpose section, ask doctor, indications & usage, dosage & administration, questions section, warning section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Keep Out Of Reach Of Children Section
Warning: Keep out of reach of children.
Purpose Section
For Relief of pain associated with: canker sores & mouth sores.
Ask Doctor
Consult your dentist or doctor before using.
Indications & Usage
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
2.5 mg per patch
Questions Section
Call us 800-4Dentek (433-6835) M-F 8am - 5am EST or email us at [email protected]
Warning 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
- citrus medica fruit
- povidone
- colloidal silicon dioxide
- carbomer 934
- Xylitol
- Hydroxypropyl
- sea salt
- magnesium stearate
* Please review the disclaimer below.
