Proctosol-HC (for the skin) is a steroid that is used to treat inflammation and itching caused by skin conditions that respond to steroid medication.

There are many brands and forms of hydrocortisone topical available. Not all brands are listed on this leaflet.

Proctosol-HC may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use exactly as directed on the label, or as prescribed by your doctor.

Do not take by mouth. Topical medicine is for use only on the skin.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and after using hydrocortisone, unless you are using this medicine to treat the skin on your hands.

Apply a thin layer of medicine to the affected skin and rub it in gently. Do not apply this medicine over a large area of skin unless your doctor has told you to.

Do not cover the treated skin area with a bandage or other covering unless your doctor tells you to. Covering treated areas can increase the amount of medicine absorbed through your skin and may cause harmful effects.

Shake hydrocortisone lotion and spay well just before each use.

If you are treating the diaper area, do not use plastic pants or tight-fitting diapers.

Stop using hydrocortisone and call your doctor if your symptoms do not improve, or if they get worse within 7 days.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

You should not use Proctosol-HC if you are allergic to it.

Tell your doctor if you have ever had:

• any type of skin infection;

• a skin reaction to any steroid medicine;

• liver disease; or

• an adrenal gland disorder.

Steroid medicines can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Do not give Proctosol-HC to a child younger than 2 years old without medical advice.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

If you apply Proctosol-HC to your chest, avoid areas that may come into contact with the baby's mouth.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

High doses or long-term use of Proctosol-HC can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Do not use Proctosol-HC to treat any skin condition that has not been checked by your doctor.

Do not get Proctosol-HC in your eyes. If contact does occur, rinse with water.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Proctosol-HC may cause serious side effects. Call your doctor at once if you have:

• worsening of your skin condition;

• redness, warmth, swelling, oozing, or severe irritation of any treated skin;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or

• possible signs of absorbing Proctosol-HC through your skin--weight gain (especially in your face or your upper back and torso), slow wound healing, thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.

Less serious side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.