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510(k) Data Aggregation
K Number
K043587Device Name
SUCRALFATE AND CARAFATE PASTE KITS
Manufacturer
PATRICK D. MCGRATH PH.D
Date Cleared
2006-02-03
(402 days)
Product Code
FRO, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PATRICK D. MCGRATH PH.D
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sucralfate HCI Topical Paste 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. This paste may be used in the management of mouth lesions of all types 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.
Device Description
Sucralfate HCI Topical Paste "10 is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of hydrochloric acid. This compounding process is intended for execution by a pharmacist, dentist, physician, podiatrist, veterinarian, other licensed prescriber or supervised staff trained to handle HCl 1.0N. The amorphous hydrogel paste formed by this reaction is intended to form a protective film that covers lesions where gastric acid or local wound bed acidity is not available or inconsistently present.
Sucralfate is reacted with HC1 1.0N in a ratio of approximately of 5 - 8 mL HCl per 5 gram sucralfate. Increased proportions of HCl produce thinner pastes. When reacted with hydrochloric acid sucralfate forms an amorphous hydrous gel that binds reversibly to wounds. Although reacted with strong acid, the polymerized sucralfate self-buffers to a pH of approximately 3.8. The sucralfate paste formed by this reaction may be administered directly to an accessible wound to provide an adherent physical covering of the wound bed.
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