Proctosol-HC (cream or suppository) is a steroid medicine that is used for temporary relief of itching, swelling, or irritation caused by hemorrhoids or other conditions around your anus (the opening to your rectum).

Proctosol-HC is also used with other medicines to treat ulcerative colitis.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Rectal medicine is for use only on your rectum.

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

Try to empty your bowel and bladder before using rectal medicine.

Wash your hands before and after using this medicine.

Remove the wrapper before inserting the suppository.

Proctosol-HC cream is for use only around the outside of your anus. Do not insert the cream into your rectum.

Call your doctor if your symptoms do not improve, or if they get worse.

Do not use this medicine to treat any condition that has not been checked by your doctor. Do not use the rectal cream to treat diaper rash.

The rectal suppository may stain your clothing or other fabrics coming into contact with this medicine.

Store at room temperature away from moisture and heat. Do not freeze.

You should not use Proctosol-HC if you are allergic to hydrocortisone or palm oil.

Tell your doctor if you have a fever or any type of infection.

Tell your doctor if you are pregnant.

You should not breastfeed while using Proctosol-HC.

Do not give this medicine to a child without medical advice.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

High doses or long-term use of steroid medicine 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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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:

• severe rectal pain or burning, bleeding from your rectum;

• new or worsening rectal irritation;

• fever or other signs of infection; or

• severe headaches, ringing in your ears, pain behind your eyes.

Common side effects of Proctosol-HC may include:

• rectal itching, burning, or other irritation; or

• dryness or skin changes around the rectum.

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.

Other drugs may affect Proctosol-HC, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.