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Orafate™ Prescribing Information

Prescribing Information - Product Package Insert
Orafate™ Polymerized Sucralfate Paste
Rx Only by Dentists, Oral Surgeons or ENT physicians
30mL Product Code: 33801-030-01
		Device UPC

Description of Device:
Orafate™ is a 10% sucralfate paste. 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 calcium chelated malic acid added to sucralfate powder converting 
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 Orafate™ paste in a multi-use 30ml tube.
FDA Indications: Orafate™ 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 those caused by periodontal and gingival 
inflammation, tooth extractions, and wounds 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.

Direction of use:
-	Following Dental Cleaning (Scaling & Root Planing): Brush ¼ teaspoon of Orafate™ 
	into gingival pocket wounds twice daily x 1 week.
-	Following Tooth Extraction: Place ¼ - ½ teaspoon of Orafate™ into wound 3 times 
	daily, then twice daily or as directed by the dentist.
-	Following Tonsillectomy or Uvuloplasty: Squeeze out ½ to 1 tsp (2.5 – 5ml) of paste 
	from bottle onto tongue, swish, gargle then expectorate as instructed by surgeon. 
	Orafate™ is safe if swallowed.
	
Other General Instructions for Dental Use:
Orafate™ should be used 2 times daily for the 1st day or as directed by the dentist or 
oral surgeon. Thereafter for 1-4 weeks apply Orafate™ in any of the following ways: 
¼ teaspoon of paste may be either: 
(a) Brushed alone or with toothpaste over affected tooth-gum line area; 
(b) Mix Orafate™ with equal portions of dentifrice (tooth paste, powder, gel) and 
    layer over areas of teeth cleaned by the dentist; 
(c) Dab Orafate™ directly on to affected gum margin; 
(d) Layer Orafate™ onto affected gum area; or 
(e) Place Orafate™ in mouth, sucked back and forth through spaces between teeth.
Length of Use: Orafate™ is to be used no longer than the time prescribed by the 
surgeon or dentist, 
ideally no longer than the period of time wherein oral wound, irritation or inflammation 
persists.
Maximal Daily Amount: Maximal daily amount of Orafate™ should not exceed 40 ml or
 8 teaspoons.
Side effects: At the time of this writing, no adverse side effects have been 
reported with the use of Orafate™.
Adverse Reaction: As with all sucralfate products, constipation may be an adverse 
reaction if Orafate™ is swallowed.
Warning: Federal law restricts Orafate™ to sale by or on the order of a physician 
or properly licensed practitioner.



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