SPL v10
SPL
SPL Set ID 2669183c-7a58-037e-e054-00144ff88e88
Route
TRANSMUCOSAL
Published
Effective Date 2015-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.5 mg)
Inactive Ingredients
Citrus Medica Fruit Carbomer 934 Povidone Hydroxypropyl Cellulose (type E) Sea Salt Xylitol Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Shape: round Size: 9 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-12-01

Description

menthol: 2.5 mg

Purpose

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


Medication Information

Purpose

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

Description

menthol: 2.5 mg

Section 51945-4

Ask Doctor

Consult your dentist or doctor before using.

Purpose Section

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

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.

Active Ingredient

menthol: 2.5 mg

Questions Section

Call us 800-4Dentek (433-6835) M-F 8am - 5am EST or email us at [email protected]

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.

Inactive Ingredients
  • citrus medica fruit
  • povidone
  • colloidal silicon dioxide
  • carbomer 934
  • Xylitol
  • Hydroxypropyl
  • sea salt
  • magnesium stearate
Dosage & Administration

2.5 mg per patch

Keep Out of Reach of Children Section

Warning: Keep out of reach of children.


Structured Label Content

Section 51945-4 (51945-4)

Ask Doctor

Consult your dentist or doctor before using.

Purpose Section

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

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.

Active Ingredient

menthol: 2.5 mg

Questions Section (Questions section)

Call us 800-4Dentek (433-6835) M-F 8am - 5am EST or email us at [email protected]

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.

Inactive Ingredients
  • citrus medica fruit
  • povidone
  • colloidal silicon dioxide
  • carbomer 934
  • Xylitol
  • Hydroxypropyl
  • sea salt
  • magnesium stearate
Dosage & Administration

2.5 mg per patch

Keep Out of Reach of Children Section

Warning: Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)