BUTTER-C
Medical devices
Mouth ulcer protective gel OEM/ODM manufacturing
Mouth Ulcer Protective Gel · Oral Mucoadhesive Gel · OEM/ODM
Mouth ulcers (canker sores) are small, shallow sores inside the mouth that sting whenever you eat spicy, sour or salty food or brush your teeth. A mouth ulcer gel on the medical device route does not act on the cause; it works like a dressing: the gel contains mucoadhesive polymers such as sodium hyaluronate, PVP and cellulose derivatives that form a film covering the ulcer, limiting direct friction from food and saliva and thereby reducing discomfort when eating and drinking. The formula contains no lidocaine, benzocaine or any other numbing agent — with those substances, the product becomes a drug. The technical challenge is keeping the film adhered for a long time in a moist environment, with a pleasant taste and safety if accidentally swallowed. Butter-C advises on the formula and packaging; classification, the registration dossier and manufacturing requirements are discussed separately for each project.
Formula base
A mucoadhesive, film-forming gel
The gel stays in the mouth and is partly swallowed, so the raw materials are oral-grade and kept few.
Mucoadhesive polymers
Sodium hyaluronate, PVP, carbomer, sodium carboxymethylcellulose, hydroxyethylcellulose — form a film and adhere to the moist mucosa.
Humectants
Glycerin, propylene glycol — keep the gel from drying hard and make it easy to spread.
Supporting ingredients
Aloe vera and licorice derivatives in supporting roles; no pharmacological claims.
Taste and preservation
Xylitol, sucralose, a light flavor; a preservative system suitable for oral care products.
Key technical points
Four factors that determine the quality of a mouth ulcer gel
Adhesion on moist mucosa
Select the polymer type and ratio so the film is not washed away by saliva right away; adhesion of each sample is tested against the approved sample.
No numbing agents
No lidocaine or benzocaine; the soothing feel comes from the protective film.
Gentle taste, no stinging
Ulcers are sensitive to sour and spicy tastes, alcohol and strong flavors — use light flavors and no alcohol; the pH is set together with the preservative system at a level that does not sting.
Safe if swallowed
Small amounts are used; oral-grade raw materials, with microbiology and heavy metals controlled.
Three formulation directions
Three common types of mouth ulcer gel
Fluid HA and PVP gel
Spreads quickly and covers a wide area; suited to multiple ulcers.
Thick long-lasting gel
Carbomer and sodium carboxymethylcellulose, adhering more firmly to a single ulcer.
Aloe vera and licorice gel
A botanical story; aloe vera and licorice only in supporting roles.
Packaging is planned with the formula
Small pointed-tip tubes to dab precisely, flip-cap tubes; single-dose sachets to carry.
Parameters we monitor
What our R&D lab measures on every sample
Below are the parameters monitored during formula development. Parameters for the medical device dossier are applied according to the relevant standards and regulations.
- pH
- Measured at manufacture and after aging.
- Viscosity
- Across temperatures and between batches.
- Adhesion
- How long the gel layer remains on a moist surface, compared with the approved sample.
- Sensory profile
- Color, odor, taste and clarity after aging.
- Microbiology
- Tested at a GLP / ISO 17025-accredited laboratory.
- Preservative performance
- Preservative efficacy (challenge) test on the final formula.
- Biocompatibility
- Assessment of mucosal irritation, sensitization and cytotoxicity — usually with reference to the ISO 10993 series.
Claims
Writing claims in line with the medical device dossier
The intended use stated on the label determines classification and the dossier. A mouth ulcer gel speaks only of the protective film and how eating, drinking and talking feel.
Forms a protective film over mouth ulcers
Instead of: claims that the ulcer closes up, as a drug would.
Helps reduce discomfort when eating, drinking and talking thanks to the film
Instead of: pain-relief or numbing claims.
Moisturizes and helps protect the affected mucosa from friction
Instead of: drug-like claims (gone for good, completely cleared).
Aloe vera, licorice
Ingredient description. Instead of: attributing pharmacological effects to herbs.
Directions
Gently pat the ulcer dry and dab on a small amount of gel to cover it completely; avoid eating or drinking right after application, as directed on the label.
Warnings
Ulcers that persist, spread or recur frequently call for consulting a medical professional; keep out of reach of children.
Manufacturing specifications
Scope of cooperation
- Texture
- Clear or slightly hazy gel that adheres to the mucosa.
- Format
- Small pointed-tip tubes, flip-cap tubes, single-dose sachets. Volume agreed during packaging selection.
- Product category
- Medical device — not covered by the cosmetic product notification. Usually classified as class A or B depending on the intended use, contact duration and site of use; official classification follows the classification rules.
- Legal basis
- Decree 98/2021/ND-CP on the management of medical devices, as amended and supplemented by Decree 07/2023/ND-CP.
- Manufacturing and documentation
- Classification, the registration dossier and manufacturing requirements are discussed separately for each project.
- Minimum order quantity
- Agreed per order.
- Packaging
- Label design following the mandatory content for medical devices, printing and packing.
Suggested product concept
HA and PVP protective film gel
A product concept to help you picture the possibilities — not a ready-made product for sale. The actual formula is developed in line with the medical device dossier.
Sodium hyaluronate and PVP
A thin film that adheres over the ulcer.
No numbing agents, alcohol-free
No stinging on application.
Light taste with xylitol
Not bitter, not spicy.
10 ml pointed-tip tube
Dabs precisely and fits in a pocket.
Customization options
What you can specify
Within the same product type, each brand targets a different group of users. Tell us your requirements in the areas below, and our team of pharmacists will advise on a matching solution.
Texture
A fluid gel that spreads widely, or a thick gel for a single spot.
Featured ingredients
Hyaluronic acid, aloe vera, licorice.
Flavor
Neutral, very light mint, mild fruit.
Target users
Adults; children with adult guidance, as directed on the label.
Documentation
An existing medical device dossier, or a new one to be prepared.
Packaging
Pointed-tip tubes, flip-cap tubes, single-dose sachets, cartons with a leaflet.
Further reading
Related topics
Alcohol-free mouthwash manufacturing
A gentle oral care product for a sensitive mouth.
Salt mouth rinse manufacturing
Keeping claims within scope for oral care products.
Film-forming throat spray manufacturing
The same film-forming mechanism on the mucosa.
Daily oral care routine
Everyday oral care habits (in Vietnamese).
How we work
From idea to finished batch
Eight steps and three milestones signed off by both sides: approved sample, notification number, finished batch. Step-by-step details (in Vietnamese) →
Get started
Tell us about the product you plan to launch
Send us your product direction and expected volume. Our team will get back to you during business hours (Vietnam time, GMT+7).
Head office: Huu Le village, Dai Thanh commune, Hanoi · Factory: Thanh Oai Industrial Cluster, Binh Minh commune, Hanoi, Vietnam
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