Medical devices · Private label
AphthacareLiquid dressing
for mouth ulcers
A liquid dressing that protects the ulcer, helps soothe pain and supports natural healing. Eating and speaking expose mouth ulcers to friction and irritation. Aphthacare forms a film over the lesion to protect this sensitive surface, clean it and maintain moisture that supports repair.
Intended for the treatment of mouth ulcers and oral wounds, this medical device is available in the Vitrobio range for adults and children aged 3 and over. Its 10 ml tube with a long applicator allows targeted application directly onto the lesion. It offers partners an oral care product to market under their own brand, based on local physical action.
Your mouth ulcer care product,
under your brand
Supporting study
Exploratory study of Aphtarine, a different historical formulation.
Population
Range available for adults and children aged 3 and over.
Indication
Film-forming liquid dressing for the treatment of mouth ulcers and oral wounds.
Benefits
for patients
- Immediate action (osmotic mechanical action).
- Helps relieve mouth ulcer pain.
- Supports the natural healing of mouth ulcers.
- Forms a protective film over the ulcer.
- Helps clean the lesion surface.
- Over 99% naturally derived ingredients.
- Proteocyanidin complex composed of 100% plant-derived ingredients.
Mode of action
Aphthacare deposits a protective osmotic film on the ulcer surface. Film-forming glycerol technology combines complementary functions acting simultaneously in contact with the lesion.
- Protecting the sensitive area. The film limits contact with irritants and friction caused by mouth movements.
- Cleaning the ulcer surface. Osmotic attraction creates an outward fluid movement that helps detach and remove debris and contaminants from the surface.
- Maintaining a moist environment. The film protects the lesion from drying out and creates conditions favourable to natural healing.
Osmotic mechanical action starts on application. The film acts on the mucosal surface, supporting natural repair mechanisms.
Supporting study · Historical Aphtarine formulation
Supporting clinical study
A historical supporting study from Vitrobio's research into mouth ulcers. This open-label exploratory study evaluated Aphtarine®, an earlier formulation distinct from Aphthacare, in participants aged 4 to 44 with minor mouth ulcers. Of 59 enrolled participants, 48 returned their questionnaire. The overall study lasted three months, with local application three times daily until the treated episode had healed.
Participants reported their healing time with Aphtarine and their recalled healing times for previous episodes. The results below concern this historical formulation.
| Reported complete healing | Episode treated with Aphtarine | Previous untreated episodes | Previous episodes with usual treatment |
|---|---|---|---|
| Within 48 hours | 29/48 — 60.4 % | 5/48 — 10.4 % | 6/40 — 15 % |
| Within three days | 36/48 — 75 % | 16/48 — 33.3 % | 16/40 — 40 % |
Complete healing means recovery of the ulcer as reported by the participant or their parent. The three-day result includes participants who had already healed at 48 hours. Comparisons rely on recollections of previous episodes.
Good local tolerability observed with Aphtarine in this supporting study.
The detailed clinical dossier is available on request under a non-disclosure agreement.
Manufacturing & quality
Certified French manufacturing
Aphthacare is manufactured in France at the Vitrobio laboratory. Its Origine France Garantie certification is issued by Bureau Veritas.
ISO 13485
Quality management system certified by GMED.
Product details
| Field | Value |
|---|---|
| Code | AP |
| Public name | Aphthacare |
| Product type | Medical device — liquid dressing |
| Regulatory class | Class IIa |
| Regulatory framework | Certified under Regulation (EU) 2017/745 (MDR) |
| Notified body | GMED |
| Population / age | Range available for adults and children aged 3 and over |
| Category | Oral care — mouth ulcers |
| Full official indication | Film-forming liquid dressing for the treatment of mouth ulcers and oral wounds |
| Composition | Film-forming glycerol, Proteocyanidin |
| Format / volume | 10 ml applicator tube |
| Shelf life before opening | 3 years |
| Storage conditions | Below 25 °C, protected from moisture; do not refrigerate or freeze |
| Shelf life after opening | 30 days |
| Legal manufacturer | Vitrobio SAS |
| Country of manufacture | France, manufactured in-house |
| Quality system | Quality management system certified to ISO 13485 by GMED |
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