CLOTIC (clotrimazole) otic solution: Uses, Side Effects and Dosage

INSTRUCTIONS FOR USE

CLOTIC ['klↄtık]

(clotrimazole)

otic solution

This Instructions for Use contains information on how to use CLOTIC.

Important Information You Need to Know Before Using CLOTIC:

• For otic use only (use in the ear).
• Use CLOTIC exactly as your healthcare provider tells you to use it.
• Apply the entire dose of CLOTIC from 1 single-dose vial, into the affected ear 2 times a day (for a total of 2 single-dose vials a day) for 14 days. Each dose should be about 12 hours apart.
• Do not use CLOTIC after the expiration date (EXP) appearing on the outer carton, pouch and single-dose container. The expiration date is the last day of that month, for example, 2025-DEC means the medicine expires December 31, 2025.

Using CLOTIC

Follow these instructions (Step 1 to Step 11) each time you use CLOTIC. Ask your healthcare provider if there is anything you do not understand.

Step 1.	Wash your hands with soap and water (Figure 1).
Step 2.	Gently clean any fluid (discharge) from the outer ear using a clean cloth or tissue (Figure 2). Do not put a cotton swab or any other object in the ear canal.
Step 3.	Remove CLOTIC from the protective foil pouch. Pull apart 1 single-dose vial of CLOTIC as shown, by tearing along the dotted lines (perforations) until it is fully separated (Figure 3). Place the unused vials back into the protective foil pouch
Step 4.	Warm the dose of CLOTIC by holding the vial in your hand for 1 to 2 minutes (Figure 4).
Step 5.	Twist off the vial cap in the direction of the arrow as shown in Figure 5.
Step 6.	The person receiving CLOTIC should be on his or her side with the affected ear up as shown in Figure 6.
Step 7.	Hold the vial of CLOTIC in your hand and place the vial close to the ear. Let the entire dose of CLOTIC fall into the affected ear (Figure 7).
Step 8.	Gently pull the outer ear lobe upward and outward (Figure 8). This will allow the ear drops to flow down into the ear canal.
Step 9.	Remain on your side with the affected ear facing upward for 1 minute (Figure 9).
Step 10.	If your healthcare provider has told you to use CLOTIC in both ears, repeat Steps 2 to 9 in the other ear.
Step 11.	Safely throw away CLOTIC vials after use.

How should I store CLOTIC?

• Store the carton at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not open the foil pouch until ready to use.
• Keep unused vials in the foil pouch to protect from humidity.
• Throw away unused vials 30 days after first opening the pouch.
• When a vial is opened, use it right away and throw away (discard) the vial after use.

Keep CLOTIC and all medicines out of the reach of children.

Manufactured by: PHARMALOOP, S.L., Pol. Industrial Azque – c/ Bolivia,15,

Alcalá de Henares, 28806 MADRID

Distributed by:

Carwin Pharmaceutical Associates, LLC

1301 Hwy 36 - Suite 11

Hazlet, NJ 07730 USA

Under license of Laboratorios Salvat, S.A.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Approved: October 2025

PATIENT INFORMATION

CLOTIC ['klↄtık]

(clotrimazole)

otic solution

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: 10/2025

What is CLOTIC?

CLOTIC is a prescription medicine used to treat adults 18 years of age and older with fungal infections in the ear called fungal otitis externa or otomycosis. CLOTIC is used in the ear only (otic use) and contains clotrimazole, an antifungal agent.

It is not known if CLOTIC is safe to use in people with ruptured eardrums (perforated tympanic membranes).

It is not known if CLOTIC is safe and effective in children less than 18 years of age.

Do not use CLOTIC if you:

• are allergic to clotrimazole. See the end of this Patient Information leaflet for a complete list of ingredients in CLOTIC.

Before using CLOTIC, tell your healthcare provider about all of your medical conditions, including if you:

• 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. Talk to your healthcare provider about the best way to feed your baby during treatment with CLOTIC.

Tell your healthcare 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 CLOTIC?

• 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 one single-dose vial, into the affected ear 2 times a day (for a total of 2 single-dose vials a day) for 14 days. 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.

What are the possible side effects of CLOTIC?

The most common side effects of CLOTIC include:

• headache
• application site pain
• ruptured eardrum (perforation of the tympanic membrane)
• ringing in your ears (tinnitus)
• tingling, tickling or a burning sensation (paresthesia)

These are not all the possible side effects of CLOTIC.

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 CLOTIC?

• Store the carton at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not open the foil pouch until ready to use.
• Keep unused vials in the foil pouch to protect from humidity.
• Throw away unused vials 30 days after first opening the pouch.
• When a vial is opened, use it right away and throw away (discard) the vial after use.

Keep CLOTIC and all medicines out of the reach of children.

General information about the safe and effective use of CLOTIC.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CLOTIC for a condition for which it was not prescribed. Do not give CLOTIC to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about CLOTIC that is written for health professionals.

What are the ingredients in CLOTIC?

Active ingredient: clotrimazole

Inactive ingredient: polyethylene glycol 400 (PEG 400)

Manufactured by: PHARMALOOP, S.L., Pol. Industrial Azque – c/ Bolivia,15, Alcalá de Henares, 28806 MADRID

Distributed by: Carwin Pharmaceutical Associates, LLC

1301 Hwy 36 - Suite 11, Hazlet, NJ 07730 USA

Under license of Laboratorios Salvat, S.A.

CLOTIC is a registered trademark of Laboratorios Salvat, S.A.

For more information, go to www.carwinpharma.com or call 1-844-700-5011.

427492-01