Product features:

LEGASED natural Warning: Contains approx. 23% alcohol by volume!
Mouth wound plasters

Designation:
LEGASED natural
Mouth wound plasters

Composition:
Macrogol, ethanol, natural resins (myrrh, benzoin, rosin) and modified cellulose.

Areas of application:
Viscous, film-forming liquid for application as a protective film for minor inflammations in the oral cavity, pressure sores, and canker sores. Protects against mechanical pressure and chemical irritants, thereby relieving existing pain.

Contraindications:
Known hypersensitivity to natural resins, especially rosin or any of the other ingredients.

Side effects
Known hypersensitivity to natural resins, especially rosin or any of the other ingredients.
In the event of any serious incidents related to the product, please contact the manufacturer and the relevant authority immediately.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

Instructions and precautions

• Contains approximately 23% alcohol.
• Do not apply to large open wounds (e.g., alveoli).
• Not to be used on children under 12 years of age.
• There is currently no, or only very limited, experience with the use of myrrh in pregnant and breastfeeding women. As a precaution, the use of LEGASED natur should be avoided during pregnancy and breastfeeding.
• If symptoms worsen during the use of LEGASED natur or if no improvement occurs within one week, a doctor or dentist should be consulted.
• Rinse mouth after swallowing.
• If you feel unwell, seek medical advice/attention.
• In case of skin contact, wash carefully with plenty of soap and water.
• If skin irritation or rash occurs, seek medical advice/attention.
• In case of eye contact, rinse cautiously with water for several minutes, removing contact lenses if present and easy to do. Continue rinsing. Immediately seek medical advice/attention.
• Remove any spilled or splashed solution as quickly as possible with alcohol or another suitable solvent (Caution: do not use water or water-based cleaning agents, as this will cause immediate precipitation), as the natural resins contained may otherwise clump together and leave stains.
• The safety data sheet can be downloaded from www.legeartis.de or requested by email at [email protected].

Type of application:
At the dental practice:
Pat the area to be treated dry and keep it as dry as possible for better adhesion. Then apply the solution to the dry mucous membrane using a suitable instrument (e.g., an applicator tip) (do not massage in) and, if necessary, briefly moisten the application site to improve film formation. If required, the solution can also be drawn from the bottle into a disposable syringe and applied precisely with a blunt, not-too-narrow needle.

At home and on the go:
To improve adhesion of the protective film, pat the area to be treated dry beforehand (e.g., with a tissue). Then, quickly and generously apply the solution with a cotton swab or, if necessary, a clean fingertip (do not massage in). Rinsing the mouth briefly with water can speed up film formation. The application can be repeated several times a day, especially after meals and before going to bed.

Further information:

• The antibacterial barrier effect of myrrh resin supports wound healing and tissue regeneration in a positive way, thus contributing to pain relief.
• Keep out of reach of children.
• Do not return any remaining solution to the container.

Durability:
LEGASED natur should not be used after the expiry date. Once opened, the product should be used within 6 months.

Storage and handling instructions:
Immediately close the LEGASED natur bottle after use and always keep it tightly closed.

Dosage form and pack sizes:
5 ml solution
20 ml solution (practice pack)

Manufacturer:
lege artis Pharma GmbH + Co. KG
PO Box 60, D-72132 Dettenhausen
Breitwasenring 1, D-72135 Dettenhausen
Telephone +49 (0) 71 57 / 56 45 - 0
Fax +49 (0) 71 57 / 56 45 50
Email: [email protected]
www.legeartis.de

This patient information leaflet was last revised in October 2021.

Source: Information from the package insert
As of May 2024