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ProThelial™ Prescribing Information 

FDA Approved Indications for Use
510(k) Number (if known): K123904
Device Name: ProThelial™ Sucralfate Malate Paste
ProThelial™ Sucralfate Malate 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. The 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.

Prescribing Information - Product Packet Insert
ProThelial™ Sucralfate Paste Rx Only
125ml Product Code: 33801-125-01		250ml Product Code: 33801-250-02
In P- Pak 500: 500ml of ProThelial™
Device UPC


Description of Device:
ProThelial™ is a 10% sucralfate paste. Sucralfate is an α-D-glucopyranoside, β-Dfructofuranosyl-, 
octakis-(hydrogensulfate), 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 
paste.
Ingredients: Sucralfate, malate, calcium carbonate, xanthan gum, calcium sulfate, purified water, methyl 
parabens,propyl parabens, sodium saccharin.
Contents: White ProThelial™ paste in a multi-use 4 oz and 8oz bottles.
Indications: ProThelial™ Sucralfate Malate 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. The 
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.

Contraindications: The administration of ProThelial™ 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: ProThelial™ is not intended for ingestion but for the management of oral ulcerations, oral 
irritations or oral mucosal wounds. However ProThelial™ is safe if swallowed in doses up to 4 grams daily for 
56 days.
Physician Swallow Evaluation: Any clinician prescribing ProThelial™ should evaluate the adequacy of 
patient’s ability to swallow so as to minimize any unintended incidental ingestion.

Direction of use:
	For Moderate Mucositis – 2.5 - 5 ml Dose
	•	For 1st day, administer dose every 8 hours. 
	•	Then one dose every 12 hours.
	For Severe Mucositis - 10 ml Dose
	•	Use 10 ml (2 teaspoons) of paste 3 times a day for the first 2 days. 
	•	Then use 10 ml twice a day
	Special Application Instructions
	•	Use tongue to apply paste throughout the mouth (as if using tongue to remove 
		peanut butter from teeth).
	•	ProThelial™ should be swished and gargled for 5 seconds, and then held in mouth 
		for 15 seconds.
	•	Then dose can be expectorated (or swallowed if so instructed by your physician).
	•	Alternatively, ProThelial™ may be applied with cotton-tipped swab to affected 
		areas of the oral mucosa.
Length of Use: ProThelial™ is to be used no longer than the time prescribed by the physician or licensed 
practitioner, ideally no longer than the period of time wherein oral ulceration, irritation or wound persists.
For patients receiving chemo-radiation: ProThelial™ is to be used continuously during entire course of 
treatment.
Maximal Daily Amount: Maximal daily amount of ProThelial™ should not exceed 40 ml or 8 teaspoons.
Side effects: At the time of producing this leaflet, no adverse effects have been reported with the use of 
ProThelial™.
Adverse Reaction: As with all sucralfate products, constipation may be an adverse reaction if ProThelial™ 
is swallowed.
Warning: Federal law restricts ProThelial™ to sale by or on the order of a physician or properly licensed 
practitioner.



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