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
