OralMedic

OralMedic

Manufacturer:

EPIEN

Distributor:

Propharm
Full Prescribing Info
Contents
HybenX.
Description
ORALMEDIC Mouth Ulcer Gel contains the patent ingredient HybenX which seeks out and extracts water from the damaged tissues on the ulcers, then, causing the damaged tissues to coagulate. This creates a white-colour seal over the ulcer that prevents contamination and covers nerve endings to provide immediate pain relief. The formation of white coating is normal, which is not caused by tissue burned or cauterization.
Excipients/Inactive Ingredients: Sulphonated phenolics, sulfuric acid, water, colloidal silica, FD&C Red #40.
Indications/Uses
ORALMEDIC Mouth Ulcer Gel is indicated in the topical treatment of ulcerating lesions of the oral cavity such as Canker and Mouth Ulcers. ORALMEDIC Mouth Ulcer Gel provides fast permanent relief from the pain and discomfort of oral mucosal ulcers with only one treatment. ORALMEDIC Mouth Ulcer Gel is not intended for the treatment of cold sores or fluid-filled blisters.
Dosage/Direction for Use
Instructions for Use: 1. ORALMEDIC Mouth Ulcer Gel works more effectively if oral lesion is dried first with a clean cotton bud or tissue.
2. Gently peel open the blister pack. Use the supplied dry cotton bud to dip into the ORALMEDIC Mouth Ulcer Gel and cover appropriate amount of gel.
3. Apply the ORALMEDIC Mouth Ulcer Gel to the affected area for 3-5 seconds. When applying, use a rolling motion to completely cover the entire ulcer area. There will be a "stinging" sensation upon application. Do not apply on area without ulcers. If it is over used, it may cause redness or swelling on the applied area.
4. After 3-5 seconds, rinse mouth thoroughly with water and spit out. Painful sensation will be relieved.
5. Dispose of swab and package in the bin.
Important: 1. Just apply appropriate amount of ORALMEDIC Mouth Ulcer Gel over the ulcers. If it is over used, it may cause irritation to the healthy tissues.
2. When applying ORALMEDIC Mouth Ulcer Gel on the ulcer, there will have a "stinging" sensation. It indicates the gel functioning. The stinging sensation will be eliminated after rinsing off.
One application per ulcer treatment is usually sufficient. However, if the ulcer pain returns shortly after rinsing with water, it is an indication that some part of the ulcer was not covered. Repeat application one more time following the previously mentioned instructions. It is not recommended that more than two treatments be performed on an individual oral ulcer.
Warnings
Keep out of the reach of children. Do not use if allergic to sulphur in any form. If it is over used, it may cause redness or swelling on the applied area. If eye exposure occurs, immediately remove any contact lenses and rinse thoroughly with water.
Special Precautions
General: ORALMEDIC Mouth Ulcer Gel is for topical use on oral cavity mucosa only. Avoid eye contact. Safety and effectiveness in pregnant women and children under the age of 12 has not been established.
Adverse Reactions
ORALMEDIC Mouth Ulcer Gel may cause local irritation upon administration. If excess irritation occurs during use, rinse thoroughly. If condition persists contact a healthcare professional.
Storage
Store at room temperature, 15°C-30°C or 59°F-86°F, in a dry place.
ATC Classification
A01AD11 - various ; Belongs to the class of other agents for local oral treatment.
Presentation/Packing
Oral gel 0.3 mL.
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