Dibucaine topical

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Dibucaine topical is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

Dibucaine is usually applied to the affected area 3 or 4 times daily. Follow the label directions about how much medicine to use and how often.

Before applying dibucaine, wash the skin with soap and water. Rinse thoroughly, and pat dry gently with a tissue or soft cloth.

Apply enough of the medicine to cover the entire area to be treated.

For hemorrhoids: Dibucaine ointment may be applied to the outside of the rectum. Do not place the medicine inside the rectum. Use after each bowel movement or up to 4 times per day to treat hemorrhoid pain and itching.

Wash your hands after applying this medicine.

It is best to use no more than 1 tube of dibucaine per day (24 hours). If you use the ointment on a child, use no more than 1/4 of a tube per day.

You may cover the treated skin area with a light bandage or gauze dressing. Avoid any covering that does not allow air to pass through it, such as plastic wrap.

Call your doctor if your symptoms do not improve after 7 days of treatment, or you have redness, irritation, swelling, bleeding, or any new symptoms.

Store at room temperature away from moisture and heat.

Since dibucaine topical is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

An overdose of dibucaine topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Do not apply this medicine near your eyes. Rinse with water if the medicine gets in your eyes.

Avoid exposure to sunlight or tanning beds. Dibucaine topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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

Although the risk of serious side effects is low when dibucaine is applied to the skin, side effects can occur if the medicine is absorbed into your bloodstream. Your body may absorb dibucaine through the skin if you use too much or if you apply it over large skin areas. Skin that is cut or irritated may also absorb more medicine.

Stop using dibucaine topical and call your doctor at once if you have:

• headache, tired feeling, shortness of breath;

• blue-colored skin;

• fast or irregular heartbeats;

• seizure (convulsions); or

• weak or shallow breathing.

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.

Also call your doctor at once if you have:

• new skin rash or irritation; or

• rectal bleeding.

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.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.