Descriptive sheet OTOFEN
Description
OtoFen DOLORE Ear Drops is a medical device whose action is based on the osmotic properties of glycerol. The main ingredient in OtoFen DOLORE Ear Drops is glycerol. The glycerol used in ear drops has two main properties:
1. the oily consistency of glycerol makes it adhere delicately to the skin at the point of application and is responsible for its protective properties;
2. The hygroscopicity of glycerol, administered topically, allows the removal of water retained in the tissues (osmotic effect), reducing swelling and therefore relieving pain.
The glycerol contained in the medical device softens earwax, facilitates its expulsion, and, due to its ability to absorb water, removes excess fluid (osmotic effect), promoting the elimination of symptoms that occur in inflammatory conditions, such as ear pain and swelling. Glycerol has a causative effect. Lidocaine is an adjuvant used as a local anesthetic, which intensifies the action of glycerol and relieves ear pain.
How to use
1. Wash your hands and unscrew the bottle cap.
2. Tilt your head or lie on your side so that the treated ear is facing upward.
3. Gently pull your earlobe (bottom part of your ear canal) away from your neck.
4. Turn the bottle of OtoFen DOLORE Ear Drops upside down without the cap and press on both sides, dispensing 2 drops of product into the ear.
5. Keep your head tilted for a few minutes so that the drops can flow into your ear canal.
6. Remove excess liquid with a clean tissue.
7. After application, it is recommended to close the external auditory canal with a cotton ball.
8. Replace the cap.
Adults and children over 12 years of age: daily. If you notice no improvement after 3 days or if your symptoms worsen, consult your doctor.
Children over 6 months: 2 drops in each ear up to three times daily. Use only under the supervision of an adult or doctor. If you notice no improvement after 3 days or if your symptoms worsen, consult your doctor or pediatrician.
Warnings
Do not use OtoFen PAIN Ear Drops:
- if the packaging has been damaged;
- if the eardrum is damaged (for example: chronic otitis media);
- OtoFen DOLORE Ear Drops must be used only after a thorough otoscopic examination by a doctor;
- if an allergy to one of the components of the product has been previously detected;
- if the expiry date printed on the package has been exceeded;
- if the patient has just undergone surgery or surgical treatment on the ear;
- in children under 6 months of age;
- in case of prolonged pain or swelling caused by inflammatory conditions of bacterial or fungal origin, these conditions require medical consultation;
- in case of otorrhea or ear discharge.
Do not apply OtoFen DOLORE Otological Drops to the ear if you wear hearing aids. OtoFen DOLORE Otological Drops should be applied one hour before inserting the hearing aid into the external auditory canal.
For external use only. Avoid contact with mucous membranes of the eyes, mouth, throat, and nose.
Conservation
Store in a dry place, at a temperature between 15°C and 25°C, in an upright position, protected from direct sunlight.
Store in a frost-free place, do not refrigerate.
Shelf life after opening: 1 month.
Format
7g bottle.