Home Orafate™ D9630

In-Office Procedure
Using Orafate™ About Orafate™ FAQs Healthcare Professionals Contact us

Frequently Asked Questions 

What Is Orafate™?
Orafate™ is a specialized formulation of sucralfate presented in gel form. In Orafate™, 
generic sucralfate compound is reversibly cross-linked into sucralfate sheets known as 
high potency sucralfate. Sucralfate sheets assume an egg-crate configuration, a novel 
configuration that allows for efficient layering of sheets in a stackable open 
“egg-crate” fashion. Sucralfate sheets of Orafate™ have unique surface effects resulting 
in several beneficial outcomes for the patient with oral surgical wounds.

What Is The Active Ingredient of Orafate™?
Orafate™ has one active ingredient high potency sucralfate which is generic sucralfate 
cross-linked by malate calcium chelates converting singular sucralfate compound into 
“sucralfate sheets”.

Is Orafate™ A Medical Device Or A Drug?
Though Orafate™ contains sucralfate, it is FDA cleared and marketed as a medical device. 
Unlike a drug, medical device has no chemical reaction to tissues of the body. Rather, 
it treats or prevents disease by a mechanical mode of action. 
Orafate™ uses a mechanical mode of action in the management of mouth lesions of all types.

Does Orafate™ Have Side Effects?
The active ingredient of Orafate™, sucralfate has no serious side effects or adverse 
reaction. Constipation has been traditionally reported with large oral doses of sucralfate.

Who Can Use Orafate™? 
Orafate™ is recommended for the following:
• 	Patients suffering from oral wounds from dental extractions, tonsillectomies or 
	uvuloplasty surgery.
• 	Patients with gingivitis & periodontal disease who have had teeth cleaning, scaling
	and root planning.
• 	Patients suffering from traumatic oral injury or laceration.
• 	Patients suffering from blisters, ulcerations or erosions from infection.
• 	Patients with thermal oral burn.
• 	Patients with caustic, chemical or acid burns to the mouth.

How Do I Use Orafate™? 
Following Tooth Extraction: Orafate™ should be used 3 times daily for the 1st daily then 
twice daily for 1 week or as directed by the dentist.
Following Tonsillectomy or Uvuloplasty: Squeeze out ½ to 1 tsp (2.5 – 5ml) of gel from 
bottle on to tongue, swish, gargle and/ or swallow the dose as instructed by surgeon.

Following Scaling and Root Planing: Orafate™ should be used 2 times daily for the 1st 
day or as directed by the dentist. Thereafter apply for four weeks.

Orafate™ as follows: ¼ teaspoon of gel may be either 
(a) brushed alone or with toothpaste over affected tooth-gum line area; 
(b) mixed with equal portions of dentifrice (tooth paste, powder, gel) and layer over 
	areas of teeth cleaned by the dentist; 
(c) dabbed directly on to affected gum margin; (d) layered onto affected gum area; or 
(e) placed in mouth, sucked back and forth through spaces between teeth.

How Long Should I Use Orafate™?
Orafate™ is to be used no longer than the time prescribed by the doctor or dentist, 
ideally no longer than the period of time wherein oral wound, irritation or 
inflammation persists.

How Is Orafate™ Different From Other Hydrogel Oral Devices? 
Orafate™ differs substantially from other oral hydrogel oral devices. Its proprietary 
system of polymerization converts generic sucralfate molecues into sucralfate sheets. 
This conversion from singular suspended sucralfate to “sheets” of sucralfate enhances 
the surface concentration or potency of sucralfate in Orafate™. Sucralfate 
‘sheets’ are termed high potency sucralfate.

Orafate™ achieves surface concentrations of sucralfate that contribute directly to its 
ability to treat oral mucosal wounds. - Only Orafate™ simultaneously facilitate healing 
by 366%, reverse gingival and periodontal inflammation without antibiotics/harsh 
chemicals, minimize associated pain, stop venous and capillary bleeding.

What Is The Maximal Daily Amount? 
Maximal daily amount of Orafate™ should not exceed 40 ml or 8 teaspoons.

How Can I Get It? 
Federal law restricts Orafate™ to sale by or on the order of a doctor, dentist or properly 
licensed practitioner.

What If Orafate™ Is Accidentally Swallowed? 
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. 
Any clinician prescribing Orafate™ should evaluate the adequacy of patient’s ability to 
swallow so as to minimize any unintended incidental ingestion.

Are There Any Special Precautions? 
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.

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