Silatrix Oral: Package Insert and Label Information

SILATRIX ORAL- sucralfate gel
SA3, LLC

SILATRIX ORAL GEL
SA3, LLC
—————————–

SILATRIX ORAL GEL
Rx only
For oral mucosa area only
Not for ophthalmic use

DESCRIPTION

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.

INGREDIENTS

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 is indicated for the treatment of oral lesions of all types including aphthous ulcer, stomatitis, mucositis, traumatic ulcers, abrasions, and wounds from oral surgery. It forms a protective layer over the mucosa by reversibly adhering to the surface allowing relief of pain and protection against further irritation.

CONTRAINDICATIONS

SILATRIX ORAL GEL is contraindicated in patients with known serious hypersensitivity to sucralfate or any of the listed ingredients.

WARNINGS

For oral mucosa area only. Avoid direct contact with eyes.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

PRECAUTIONS


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.

DOSAGE AND ADMINISTRATION

Apply to mucosal wounds 2 to 3 times daily.

HOW SILATRIX ORAL GEL IS SUPPLIED

SILATRIX ORAL GEL is supplied in:
10 gram (0.35 oz) tube
NDC: 69420-8351-1

STORAGE:

Store at 20°-25°C (68° to 77°F); Keep away from heat and protect from freezing. [See USP Controlled Room Temperature.]
MANUFACTURED FOR:
SA3, LLC
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 Gel
Polymerized Sucralfate Gel 10%
(1 gm/10 gm)
10 gram (0.35 oz)
NDC: 69420-8351-1
(click image for full-size original)

SILATRIX ORAL sucralfate gel
Product Information
Product Type Item Code (Source) NHRIC:69420-8351
Route of Administration ORAL DEA Schedule
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:69420-8351-1 10 GEL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
PREMARKET NOTIFICATION K202000 02/17/2021
Labeler — SA3, LLC (079627454)

Revised: 03/2021 SA3, LLC

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