Instructions for use
Product
OtoMel® ear drops, 10 ml vial
Product description
OtoMel® is a soothing lotion containing pure honey to care for and protect the external ear canal. OtoMel® can be applied when the skin inside the ear is irritated. OtoMel® relieves itching and supports the recovery of the skin barrier. OtoMel® is also suitable for the treatment of eczema.
Ingredients
Aqua, Pure Honey, Glycerin, Sorbitol, Potassium Sorbate.
Indication
OtoMel® can be applied to care for and protect the external ear canal.
OtoMel® can be used for:
• Irritation
• Itching
• Dry skin
• Redness
• Eczema
Mode of application
• Heat OtoMel® to body temperature by holding the vial in your hand for several minutes. Using cold ear drops can cause dizziness.
• Apply 1 to 3 ear drops at a time in the ear canal 1 to 3 times a day.
• You can also apply OtoMel® by cutting the gauze to size, rolling it up, and placing it inside the ear. Then you can apply OtoMel® on the gauze and let it be absorbed.
Usage during pregnancy or when breastfeeding
There are no indications that OtoMel® should not be used during pregnancy or while breastfeeding.
When not to use
• Do not use when you are known to be hypersensitive to honey or one of the other ingredients.
• Do not apply when you have a perforated eardrum caused by, for example, an ear infection.
• Do not use when the packaging is damaged when receiving the product.
• Do not use after the expiry date has passed.
• Do not use for children under 12 years old.
Special attention and precautions
• Use for a maximum of 30 consecutive days.
• Cold ear drops can cause dizziness. Therefore, heat the ear drops to body temperature by holding the vial in your hand for several minutes.
• Do not touch the ear with the vial while applying the drops to prevent contamination of the ear drops.
• Re-apply gauze regularly and do not leave it in the ear canal for more than 24 hours.
• Consult your physician if your symptoms do not improve or if you are experiencing new symptoms.
• Keep out of reach of children.
Adverse events
• If there are severe adverse events related to the device, these should be reported to the manufacturer and the competent authorities (of the member state) in which the user is located.
Storage conditions
• The expiry date is mentioned on the packaging.
• Can be stored for up to 12 months after opening.
• Store between 4°C and 30°C.
