Uses of Acetasol HC:

• It is used to treat ear infections.

What do I need to tell my doctor BEFORE I take Acetasol HC?

• If you have an allergy to acetic acid, propylene glycol, hydrocortisone, or any other part of Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone).
• If you are allergic to Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone); any part of Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Chickenpox, herpes infection, ruptured eardrum, or smallpox-like virus.

This is not a list of all drugs or health problems that interact with Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Acetasol HC?

• Tell all of your health care providers that you take Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone). This includes your doctors, nurses, pharmacists, and dentists.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Acetasol HC) best taken?

Use Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• For the ear only.
• Wash your hands before and after use.
• Lie on your side with problem ear up.
• For children younger than 3 years of age, pull the outer ear outward and downward.
• For children 3 years of age and older and adults, pull the outer ear outward and upward.
• Put drops in ear without touching dropper to ear. Stay on side for 2 minutes or put cotton plug in ear.
• If you have been told to use a wick of cotton to put Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone) in, follow what the doctor has told you.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Irritation where Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone) is used.
• Very bad ear pain.

What are some other side effects of Acetasol HC?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.
• Stinging.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Acetasol HC?

• Store at room temperature.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Acetasol HC (acetic acid, propylene glycol diacetate, and hydrocortisone), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.