Patient information: uses, side effects, how to take - Xtoro
What is XTORO?
XTORO is a prescription medicine that is used to treat bacterial infections of the external ear canal, with or without an otowick in people 1 year of age and older.
It is not known if XTORO is safe and effective in children under 1 year of age.
Before using XTORO, tell your healthcare provider about all of your medical conditions, including if you:
- allergic to any antibacterial including fluoroquinolones or to any of the ingredients in XTORO. See the end of this Patient Information leaflet for a complete list of the ingredients in XTORO.
are pregnant or plan to become pregnant. It is not known if XTORO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if XTORO can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with XTORO.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use XTORO?
- XTORO is for use in the ear only. Do not use XTORO in the eyes or mouth.
- Use XTORO exactly as your healthcare provider tells you to take it.
- Read the Instructions for Use that comes with XTORO.
What are the possible side effects of XTORO?
XTORO may cause serious side effects, including:
- Growth of yeast or fungi. XTORO may cause growth of yeast or fungi during long term use. Stop using XTORO if you develop a growth of yeast or fungi.
- Allergic reactions. Stop using XTORO and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of an allergic:
- rash
- hives
- swelling of your face, lips, mouth, or tongue
- itching
- trouble breathing
- dizziness, fast heartbeat, or pounding in your chest.
The most common side effects of XTORO include:
- itching in the ear
- nausea
Tell your healthcare provider if you have any side effects that bothers you or does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store XTORO?
- Store XTORO between 36°F to 77°F (2°C to 25°C).
- Do not freeze XTORO.
Keep XTORO and all medicines out of the reach of children.
General Information about the safe and effective use of XTORO.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XTORO for a condition for which it was not prescribed. Do not give XTORO to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about XTORO. You can ask your pharmacist or healthcare provider for information about XTORO that is written for healthcare professionals.
What are the ingredients in XTORO?
Active ingredients: finafloxacin, 0.3%
Inactive ingredients: sodium chloride, hydroxyethylcellulose, tyloxapol, magnesium chloride, and purified water. Hydrochloric acid and sodium hydroxide may be added to adjust pH.
U.S. Patent Nos: 8,536,167; 9,119,859; 9,504,691; 9,993,483
©2026 Fonseca Biosciences, LLC
Manufactured For: Fonseca Biosciences, LLC 2807 Long Beach Blvd Ste 1A Long Beach Township, New Jersey 08008 USA
1-877-436-6732
medinfo@fonsecabio.com
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 3/2026
PATIENT INSTRUCTIONS FOR USE XTORO (ex tore’ oh) (finafloxacin otic suspension) 0.3% for topical otic use |
Important information you need to know before using XTORO.
How should I use XTORO?
Wash your hands with soap and water.
Hold the bottle in your hands for 1 to 2 minutes to warm XTORO (see Figure 1). Using cold drops may cause dizziness. Shake the bottle of XTORO well before use. 
Lie down on your side with the affected ear facing up (see Figure 2).  Squeeze the bottle and put 4 drops of XTORO into the affected ear (see Figure 3). If otowick is in place, put 4 drops of XTORO into the affected ear at the surface of the otowick. Do not touch the ear, fingers or any other surfaces with the tip of the bottle as it could contaminate the drops. 
Gently pull the outer ear lobe upward and backward (see Figure 4). This will allow the ear drops to flow down into the ear canal. 
Stay on your side with the affected ear facing up for at least 60 seconds. Repeat Steps 3-5 for the other ear if both ears are infected. How should I store XTORO?
Keep XTORO and all medicines out of the reach of children. Fonseca Biosciences, LLC Long Beach Township, New Jersey 08008 |
This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: 3/2026