Description
CE Medical Device, Class I.
Predosed ear drops.

How to use
- Tilt your head to the side and squeeze the bottle to instill 3-6 drops into the ear canal.
- Ensure that Debrox drops remain in the ear for 1 or 2 hours, keeping your head tilted or inserting a cotton ball to prevent the product from leaking out.
- Gently remove any liquid that has leaked from the ear canal.
- In case of earwax blockage, perform a thorough rinse with lukewarm water at the end of the treatment to remove earwax residues, being careful not to direct water jets directly onto the eardrum.
To remove earwax blockage
- Instill 3-6 drops of Debrox in each ear.
- Repeat the treatment twice a day for 3-6 days.
To prevent its formation
Instill a few drops of Debrox once a week.

Components
Glycerin, hydrogen peroxide, urea, sodium lauryl sarcosinate, propylene glycol, purified water, trisodium citrate, citric acid monohydrate.

Warnings
Product for external use.
Do not use in case of allergy/hypersensitivity to any of the formulation's components.
Avoid contact with eyes. Rinse eyes immediately in case of contact with the product.
Avoid using the product if there are confirmed or suspected lesions of the external auditory canal and/or the tympanic membrane.
Do not use in the presence of hearing aids.
If other products or medicines are to be applied, wait the necessary time before proceeding with Debrox instillation to ensure treatment effectiveness and limit possible interactions.
Do not swallow; if swallowed, contact a doctor quickly.
The use of Debrox is not known to affect the ability to drive vehicles or operate machinery. However, earwax accumulation can cause dizziness and/or hearing loss, and these conditions may be temporarily aggravated by the application of the drops. Should such effects occur, wait for them to subside before undertaking any dangerous activity (e.g., operating machinery) or driving.
Debrox can be used during pregnancy and breastfeeding. The ingredients have been widely used in similar devices for many years, with no reported issues.
However, no clinical studies have been conducted on this.
Do not share the bottle with other people to avoid the transmission of any possible infections.
Keep out of reach of children.
Consult a doctor if:
- persistent burning occurs;
- symptoms are still present at the end of treatment;
- there is a worsening of symptoms caused by earwax blockage (e.g., irritation, pain, hearing loss, dizziness, and tinnitus).
Do not use if the packaging is damaged.

Storage
Do not store above 25°C.
Keep the bottle tightly closed and avoid exposure to excessive heat or direct light.
Close the bottle after use and use within 30 days of first opening.

Format
15 ml bottle, with predosed dropper.