Full Prescribing Information

Ingredients: Water, Maltodextrin, Propylene Glycol, Polyvinylpyrrolidone (PVP), Sodium Hyaluronate, Potassium Sorbate, Sodium Benzoate, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Disodium Edetate, Benzylkonium Chloride, Flavoring, Saccharin Sodium, Glycyrrhetinic Acid.

Pharmaceutical Form: Concentrated oral gel

Contents: 15 mL per single-use packet.  Commercial boxes contain either 15 single-use packets (NHRIC 89141-456-02) or 90 single-use packets (NHRIC 89141-456-03)

Therapeutic group: Oral gel for the relief and management of pain

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.

Contraindications: The administration use of Gelclair is contraindicated in any patient with a known or suspected hypersensitivity to any of its ingredients.

Special Precautions for Use: Avoid eating or drinking for at least 30-60 minutes after use. Do not use any packet that is not intact (torn, split, or otherwise damaged in any way). If no improvement is noticed after 7 days, consult a physician.

Keep out of the reach of children.

Warning: Federal law restricts Gelclair to sale by or on the order of a physician or properly licensed practitioner.

Interaction with other medicinal products and other forms of interaction: There are no known interactions with medicinal or other products.

Directions for Use: Pour the entire contents of the single-use Gelclair packet into a glass and add 1 tablespoon of water. If this dilution of Gelclair is too thick, it may be diluted with an additional 1-2 tablespoons of water to achieve the desired thickness. Stir mixture well and use immediately. Rinse around the mouth for at least 1 minute or as long as possible to coat tongue, palate, throat, inside of cheeks and all oral tissue thoroughly. Gargle and spit out. Use 3 time s a day or as needed. Do not eat or drink for at least 30-60 minutes following treatment. If water is not available, Gelclair may be used undiluted. If Gelclair is swallowed accidently, no adverse effects are anticipated.

Side effects:  At the time of producing this brochure, no adverse effects have been reported in clinical trials with the use of Gelclair. Postmarketing reports have included infrequent complaints of burning sensation in the mouth.

Overdose: At the time of producing this leaflet, no cases of overdose have been reported.

Storage: Store at room temperature, out of direct sunlight. The gel may become a little darker and thicker over time, but this does not affect its efficacy or safety. Do not use after the expiration date shown on the box and packet.

Date of last revision: August 2015 / GS 1103 012015

GELCLAIR® is a registered trademark of Helsinn Healthcare SA, Lugano, Switzerland.

Manufactured for: Helsinn Healthcare SA, Lugano, Switzerland
Marketed and distributed by: DARA BioSciences Inc., Raleigh, NC 27615
DARA BioSciences Inc.   Call 1-855-327 2246 or info@DARABio.com