Clotic

Clotic is an antifungal ear drop used to treat fungal otitis externa (otomycosis) in adults 18 years and older. This otic solution contains clotrimazole, an antifungal medication that targets fungal ear infections caused by:

• Aspergillus species
• Candida species.

Key Features of Clotic Ear Drops

• Generic name: Clotrimazole ear drops
• Use: Fungal otitis externa
• Eligibility: Adults 18+
• Administration: Twice-daily application
• Course length: 14 days
• FDA approval: September 26, 2025
• Formulation: Single-dose vial
• Drug class: Azole antifungal agent

Clotic contains clotrimazole, an azole antifungal agent that works by:

• Blocking fungal enzyme production that fungi need to survive
• Damaging fungal cell walls, causing the cells to break down and die
• Disrupting fungal growth by interfering with essential cell processes.

Approved For:

• Adults 18 years of age and older
• Patients with fungal otitis externa (otomycosis)
• Infections caused by Aspergillus and Candida species
• Patients with intact eardrums (tympanic membranes)

NOT Recommended For:

• Children under 18 years of age
• Patients with perforated eardrums (ruptured tympanic membranes)

Contraindications:

Do not use Clotic if:

• You are allergic to clotrimazole or any ingredients in Clotic
• Check the ingredient list at the end of this guide.

Important: Clotic has only been studied in patients with intact tympanic membranes. Its safety and effectiveness in patients with perforated eardrums have not been established.

Read the detailed Instructions for Use that come with Clotic.

• Use Clotic exactly as your healthcare provider tells you to use it.
• Clotic is for use in the ear only (otic use).
• Clotic comes as a liquid in single-dose vials.
• Warm the dose of Clotic by holding the vial in your hand for 1 to 2 minutes to prevent dizziness.
• Apply the entire dose of Clotic from a single-dose vial into the affected ear 2 times a day.
• Each dose should be about 12 hours apart.
• If your symptoms do not improve after 14 days of treatment with Clotic, call your healthcare provider.

Before using Clotic, inform your healthcare provider about all your medical conditions, especially if you:

• Have had a perforated eardrum or eardrum damage
• Are pregnant or plan to become pregnant. It is not known if Clotic will harm your unborn baby
• Are breastfeeding or plan to breastfeed. It is not known if Clotic can pass into your breast milk. Discuss with your healthcare provider the best way to feed your baby during treatment.

Common Side Effects

The most commonly reported side effects of Clotic include:

• Headache
• Application site pain (ear discomfort)
• Eardrum perforation (ruptured tympanic membrane)
• Tinnitus (ringing in the ears)
• Paresthesia (tingling, tickling, or burning sensation).

Important: This is not a complete list of side effects. Contact your healthcare provider if you notice any concerning symptoms. You may report side effects to the FDA at 1-800-FDA-1088.

Standard Dosage:

• Target: Affected ear only
• Frequency: 2 times daily (every 12 hours)
• Duration: 14 days
• Amount: Entire contents of 1 single-dose vial per application
• Total daily use: 2 single-dose vials per day.

Step-by-Step Application Instructions

• Warm the medication. Hold the vial in your hand for 1-2 minutes before use to prevent dizziness
• Open single-dose vial. Use immediately after opening
• Apply the entire dose. Instill the complete contents into the affected ear
• Maintain the dosing schedule. Space your doses approximately 12 hours apart
• Complete the full course. Continue treatment for the full 14 days
• Discard the vial. Throw away the single-dose vial after each use

When to Call Your Doctor

• Symptoms do not improve after 14 days of treatment
• Symptoms worsen during treatment
• New symptoms develop

Tell your healthcare provider about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be aware of the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you receive a new medicine.

Temperature Requirements:

• Store at room temperature: 68°F to 77°F (20°C to 25°C)
• Keep in original carton

Humidity Protection:

• Do not open the foil pouch until you are ready to use it
• Keep unused vials in the foil pouch to protect from humidity
• Discard unused vials 30 days after you first open the pouch

Single-Dose Vial Handling:

• Use immediately after opening
• Throw away the vial after use - do not save or reuse

Expiration Date:

• Do not use after the expiration date (EXP) on the carton, pouch, and vial
• Date format example: 2025-DEC means it expires on December 31, 2025

Safety:

• Keep Clotic and all medicines out of reach of children

Active Ingredient: Clotrimazole (antifungal agent)

Inactive Ingredient: Polyethylene glycol 400 (PEG 400)

Clotic is manufactured for Laboratorios Salvat, S.A., and is manufactured by Pharmaloop, S.L. Pol. Industrial Azque – c/ Bolivia, 15 Alcalá de Henares, 28806 Madrid.