Home Orafate™ D9630

In-Office Procedure
Using Orafate™ About Orafate™ FAQs Healthcare Professionals Contact us
 
What is Orafate™ ?
Pharmacology
FDA Cleared
 
 

About Orafate™ 

FDA Cleared 

FDA Approved Indications for Use
510(k) Number (if known): K123904

Device Name: Orafate™ Sucralfate Malate Gel
Orafate™ (Sucralfate Malate 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 gel 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.

PRESCRIBING INFORMATION - PRODUCT PACKAGE INSERT
Orafate™ Sucralfate Gel     Rx Only by Dentist and ENT physicians 30mL  NDC 
58693-03-01
   
Description of Device:
Orafate™ is a 10% sucralfate gel.  Sucralfate is an  α-D-glucopyranoside,  
β-Dfructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex, molecular weight 
of 2,086.75  having the following structure:


Water containing malic acid added to sucralfate powder converts sucralfate granules 
into a polymerized gel.

Ingredients: Sucralfate, malate, calcium carbonate, xanthan gum, calcium sulfate, 
purified water, methyl parabens, propyl parabens, sodium saccharin.
Contents:  White Orafate™ gel in a multi-use 4 oz and 8oz bottles.
FDA Indications: Orafate™ Sucralfate Malate 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 gel 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. 
Contraindications: The administration of Orafate™ is contraindicated in any 
patient with a known or suspected hypersensitivity to any of its ingredients.
Special precautions for use: Do not use any product jar that is not intact or 
otherwise damaged in any way. Avoid eating or drinking for at least 1 hour after use.  
For Oral Use: Orafate™ is not intended for ingestion but for the management of oral 
ulcerations, oral irritations or oral mucosal wounds. However Orafate™ is safe if 
swallowed in doses up to 4 grams daily for 56 days.  
Physician Swallow Evaluation: Any clinician prescribing Orafate™ should evaluate 
the adequacy of patient’s ability to swallow so as to minimize any unintended incidental 
ingestion.


          Copyright© Mueller Medical International LLC 2020. All rights reserved.