Duobrii Lotion contains a combination of halobetasol and tazarotene. Halobetasol is a highly potent steroid. Tazarotene is a compound similar to vitamin A.

Duobrii Lotion is a prescription medicine used to treat plaque psoriasis (raised, silvery flaking and redness of the skin) in adults.

It is not known if Duobrii is safe and effective in children under 18 years of age.

Duobrii Lotion can cause birth defects. Do not use if you are pregnant. Use effective birth control to prevent pregnancy.

Stop using this medicine and tell your doctor right away if you become pregnant, if you stop using birth control, or if you miss a menstrual period.

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

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

If you apply this medicine after taking a shower or bath, dry your skin completely before applying the lotion.

Wash your hands before and after using this medicine, unless you are treating 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 use more than 50 grams of Duobrii Lotion in 1 week.

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.

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

You should stop using the medicine once your skin symptoms are controlled.

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

Usual Adult Dose for Plaque Psoriasis:

Apply a thin layer of lotion to the affected area(s) once daily; discontinue therapy when control is achieved

Use: For the topical treatment of plaque psoriasis

You should not use Duobrii if you are allergic to halobetasol or tazarotene, or if you are pregnant.

To make sure Duobrii is safe for you, tell your doctor if you have ever had:

• eczema;

• any type of skin infection;

• 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 use Duobrii Lotion if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

You may need to have a negative pregnancy test before starting this treatment. You should start using Duobrii Lotion during a normal menstrual period, to be sure you are not pregnant.

Stop using this medicine and tell your doctor right away if you become pregnant, if you stop using birth control, or if you miss a menstrual period.

It may not be safe to breastfeed while using halobetasol and tazarotene. Ask your doctor about any risk. If you apply this medicine to your chest, avoid areas that may come into contact with the baby's mouth.

This medicine is not approved for use by anyone younger than 18 years old.

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 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.

Do not use on sunburned skin, open wounds, or areas of eczema. Wait until these conditions have fully healed before using Duobrii Lotion.

Avoid applying this medicine to your face, underarms, or groin area. Avoid getting the medicine in your eyes, mouth, or vagina.

Duobrii Lotion could make you sunburn more easily. Avoid sunlight or tanning beds. 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 to Duobrii Lotion: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• irritation of treated skin;

• a sunburn;

• 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 Duobrii side effects may include:

• burning, stinging, redness, itching, pain, or swelling of treated skin;

• redness or crusting around your hair follicles;

• rash;

• peeling skin; or

• thinning skin.

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.

Tell your doctor about all your other medicines, especially:

• an antibiotic or other medicine that can make your skin more sensitive to sunlight; or

• any other steroid medicine used on the skin, taken by mouth, or injected.

This list is not complete. Other drugs may interact with halobetasol and tazarotene topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.