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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 an amorphous hydrogel that serves as a physical, protective barrier over the oral mucosa to protect against further irritation and relieve pain associated with mouth lesions. The hydrogel is formed during manufacturing by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution.

Silatrix Oral Gel contains sucralfate, malic acid, calcium carbonate, calcium sulfate dihydrate, sucralose, xanthan gum, propylene glycol, and purified water, as well as pentylene glycol and glycerin-ethyl lauroyl arginate HCl that are used as preservatives. Silatrix Oral Gel, which is labeled for prescription use only, is supplied non-sterile in a 10g tube.

The formulation is identical to the predicate device except for the addition of the two preservatives used to ensure device stability over the labeled shelf life.

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