SILATRIX ORAL- sucralfate
SILATRIX ORAL GEL
SILATRIX ORAL GEL
For oral mucosa area only
Not for ophthalmic use
SILATRIX ORAL GEL is an amorphous hydrogel formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain.
Silatrix Oral Gel may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucralfate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 — 7 .0.
SILATRIX ORAL GEL contains sucralfate, malic acid, calcium carbonate, calcium sulfate dihydrate, sucralose, xanthan gum, propylene glycol, and purified water.
INDICATIONS AND USES
SILATRIX ORAL GEL forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.
SILATRIX ORAL GEL is contraindicated in patients with known serious hypersensitivity to sucralfate or any of the listed ingredients.
For oral mucosa area only. Avoid direct contact with eyes.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
Stop use and ask a doctor if irritation develops. SILATRIX ORAL GEL has no known serious side effects or adverse reactions. This medication should be used as directed by your physician during pregnancy or while breastfeeding. Consult your doctor about the risks and benefits.
CAUTION: Federal law restricts this device to sale by or on the order of a physician or other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.
Apply to mucosal wounds 2 to 3 times daily.
SILATRIX ORAL GEL is supplied in:
10 gram (0.35 oz) tube
Store at 20°-25°C (68° to 77°F); Keep away from heat and protect from freezing. [See USP Controlled Room Temperature.]
Los Angeles, CA 90064
PRINCIPAL DISPLAY PANEL
Silatrix Oral Gel
Polymerized Sucralfate Gel 10%
(1 gm/10 gm)
10 gram (0.35 oz)NDC: 69420-8351-1
|SILATRIX ORAL sucralfate gel|
|Labeler — SA3, LLC (079627454)|
Revised: 01/2022 SA3, LLC
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