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GELCLAIR® Bioadherent Oral Gel
Ingredients: Water, Maltodextrin, Propylene Glycol,
Polyvinylpyrrolidone (PVP), Sodium Hyaluronate, Potassium
Sorbate, Sodium Benzoate, Hydroxyethylcellulose, PEG-40
Hydrogenated Castor Oil, Disodium Edetate, Benzalkonium
Chloride, Flavoring, Saccharin Sodium, Glycyrrhetinic Acid.
Pharmaceutical form: Concentrated oral gel
Contents: 15 mL per single-use packet. Commercial
boxes contain 15 single-use packets. (NDC 24477-010-15)
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 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 1 hour 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 times a day or as
needed. Do not eat or drink for at least 1 hour following
treatment. If water is not available, GELCLAIR®
may be used undiluted. If GELCLAIR® is swallowed
accidentally, no adverse effects are anticipated.
Side effects: At the time of producing this leaflet,
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.
GELCLAIR® is a registered trademark of Helsinn
Healthcare SA, Lugano, Switzerland.
Manufactured for: Helsinn Healthcare SA, Lugano, Switzerland
Marketed and distributed by: EKR Therapeutics, Inc., Cedar
Knolls, NJ 07927
Date of revision: October 2006
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