Halobetasol topical is a super high potency, Class I corticosteroid product that is applied to the skin to reduce inflammation and itching caused by plaque psoriasis or other skin conditions that respond to corticosteroid medication.

Halobetasol topical is available as a cream, ointment, lotion, or foam:

• Halobetasol propionate 0.05% foam: Lexette foam           
• Halobetasol propionate 0.05% cream/ointment/lotion: Ultravate cream/ointment/lotion
• Halobetasol propionate 0.01% lotion: Bryhali lotion

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.

Halobetasol (halobetasol propionate) is a highly potent, Class I corticosteroid that can be absorbed through the skin into the bloodstream and cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency, including Cushing’s syndrome, hyperglycemia, and glucosuria. Do not use for longer than 2 weeks and do not exceed the recommended dose. Periodic monitoring for HPA suppression may be required.

Before taking this medicine

You should not use halobetasol topical if you are allergic to it.

Halobetasol topical should not be applied to lesions that are exuding serum or to skin folds (where two areas of skin touch each other).

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.

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

Children are more susceptible to systemic absorption of topical corticosteroids. Most preparations of halobetasol topical are not approved for use by anyone younger than 12 years old. Some brands or forms of this medicine are for use only in adults 18 and over.

It is not known whether halobetasol topical will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use halobetasol topical, use a small amount for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to use halobetasol topical, use a small amount for the shortest time possible. Do not apply to the breasts.

Halobetasol comes in ointment, cream, foam, and lotion for use on the skin. Halobetasol topical is usually applied once or twice a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use halobetasol topical exactly as directed. Do not apply more or less of it or use it more often than prescribed by your doctor. Do not apply it to other areas of your body or use it to treat other skin conditions unless directed to do so by your doctor.

Your skin condition should improve during the first 2 weeks of your treatment. Call your doctor if your symptoms do not improve during this time.

To use halobetasol topical, apply a small amount of cream, ointment, foam, or lotion to cover the affected area of skin with a thin even film and rub it in gently.

Halobetasol foam is flammable. Stay away from open fire, flames, and do not smoke while you are applying halobetasol foam, and for a short time afterwards.

This medication is only for use on the skin. Do not let halobetasol topical get into your eyes or mouth and do not swallow it. Avoid use on the face, in the genital and rectal areas, and in skin creases and armpits unless directed by your doctor.

Do not wrap or bandage the treated area unless your doctor tells you that you should. Such use may increase side effects.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Use halobetasol exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take it by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or sunburned, windburned, dry, or irritated skin. Rinse with water if halobetasol gets in your eyes or mouth.

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

Shake the foam before each use.

• Apply a thin layer of halobetasol topical to the affected area once or twice daily as directed by your doctor. Rub in gently and completely. 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.
• Halobetasol is for short-term use only (2 weeks, or up to 8 weeks for psoriasis). Follow your doctor's dosing instructions very carefully. Do not use more than 50 grams per week.

Call your doctor if your symptoms do not improve after 2 weeks (8 weeks for psoriasis), or if they get worse. Stop using the product if your symptoms improve sooner.

You should not use halobetasol topical if you are allergic to it.

Halobetasol topical should not be applied to lesions that are exuding serum or to skin folds (where two areas of skin touch each other).

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.

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

Children are more susceptible to systemic absorption of topical corticosteroids. Most preparations of halobetasol topical are not approved for use by anyone younger than 12 years old. Some brands or forms of this medicine are for use only in adults 18 and over.

It is not known whether halobetasol topical will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use halobetasol topical, use a small amount for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to use halobetasol topical, use a small amount for the shortest time possible. Do not apply to the breasts.

Apply the product 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 halobetasol topical 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze the foam product.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

• Avoid applying halobetasol topical to your face, scalp, underarms, or groin area.
• Do not use halobetasol topical to treat any skin condition that has not been checked by your doctor.
• Avoid using other topical steroid medications on the areas you treat with halobetasol unless your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction to halobetasol, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening of your skin condition;
• redness, warmth, swelling, oozing, or severe irritation of any treated skin;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or
• possible signs of absorbing this medicine 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.

Common halobetasol side effects may include:

• burning, stinging, itching, or dryness of treated skin;
• pain where the foam was applied;
• redness or crusting around your hair follicles;
• stretch marks;
• spider veins;
• headache; or
• cold symptoms such as stuffy nose, sneezing, and a sore throat.

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.

Halobetasol topical is unlikely to interact with other medications you may take. But you should not use it with other topical or oral corticosteroids, because they may have an additive effect.

Tell your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to halobetasol. Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.