GELCLAIR® ORAL GEL FOR THE TREATMENT OF MOUTH ULCERS AND PAIN

GELCLAIR® is a prescription gel that works locally to gently soothe the pain of oral mucositis for several hours at a time

Indications: GELCLAIR® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.

HOW IT WORKS

GELCLAIR® contains ingredients that soothe, coat, and hydrate the lining of the mouth, and may reduce the severity of oral mucositis and associated symptoms like pain and problems eating normally. Because GELCLAIR® doesn’t contain alcohol or numbing agents, there should be no stinging, drying, or numbing when you use it for the treatment of mouth ulcers and mouth pain.

GELCLAIR® works rapidly; in clinical trials, patients experienced a significant reduction in pain following the first application. A majority of patients reported pain relief and the ability to eat and drink more comfortably, with improvements in the severity of oral mucositis within 2 to 3 days.

GELCLAIR® comes in a portable gel packet and may be diluted with water or used without dilution.

Follow these steps for pain relief of oral mucositis

  1. Pour the entire contents of the single-dose GELCLAIR® packet into a glass and add 1 tablespoon of water (15 mL). If the solution is too thick, you can dilute it with an additional 1 to 2 tablespoons of water until you have a consistency you like. If water is not available, or if you prefer, GELCLAIR® may be used undiluted.
  2. Stir mixture well and use immediately.
  3. Rinse around the mouth for at least 1 minute or as long as possible to thoroughly coat all of your mouth tissue—tongue, palate, throat, and the inside of your cheeks.
  4. Gargle and spit out.
  5. Wait at least 30 to 60 minutes before eating or drinking.
  6. Discard unused solution.

How to use Gelclair® treatment for oral ulcers

HOW TO ORDER

GELCLAIR® is available for purchase by US healthcare providers, hospital pharmacies, and other dispensing pharmacies through authorized distributors: Cardinal Health Specialty and CuraScript SD.

If you do not have an established account with either Cardinal Health Specialty or CuraScript SD, please contact their representatives who will collect the necessary information to process your request:

  • 866-677-4844 Cardinal Health Specialty
  • 877-599-7748 CuraScript SD

If you are a patient and are interested in GELCLAIR®, you will first need a prescription from your Healthcare Provider. Your local pharmacy can order GELCLAIR® through either Cardinal Health Specialty or CuraScript SD.

SAMPLES PROGRAM

Healthcare Providers

If you are a healthcare provider, use this form to request samples for your patient or practice. In compliance with the applicable laws and regulations, incomplete request forms cannot be processed and supplies will not be forwarded. All fields in the form are mandatory.

Request samples

Requesting samples for yourself or someone you care for

We currently require that sample requests are made by healthcare providers on behalf of patients. Please ask your healthcare provider to request samples for you and direct them to gelclair.com/sample-request-form.

Helsinn Therapeutics (U.S.) Inc. reserves the right to decline requests for samples from practitioners whose medical practice and/or patient population is deemed inconsistent with the approved product indication(s).

INDICATIONS

GELCLAIR® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.

IMPORTANT SAFETY INFORMATION

  • Do not use GELCLAIR® if there is a known or suspected hypersensitivity to any of its ingredients.
  • No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.
  • If GELCLAIR® is swallowed accidentally, no adverse effects are anticipated.
  • If no improvement is seen within 7 days, a physician should be consulted.

You are encouraged to report negative side effects of prescription medical products to the FDA.
Visit www.fda.gov/safety/medwatch, call 1-855-273-0468 or fill-in the form at this link.

Please see full Prescribing Information.

 

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