Patient information: uses, side effects, how to take - Halobetasol

What is Halobetasol Propionate Topical Foam?

Halobetasol Propionate Topical Foam is a prescription corticosteroid medicine used on the skin to treat plaque psoriasis in people 12 years of age and older. It is not known if Halobetasol Propionate Topical Foam is safe and effective in children under 12 years of age.

Before using Halobetasol Propionate Topical Foam, tell your healthcare provider about all of your medical conditions, including if you:

have had irritation or other skin reaction to a steroid medicine in the past.
have a skin infection. You may need medicine to treat the skin infection before using Halobetasol Propionate Topical Foam.
have diabetes.
have adrenal gland problems.
have liver problems.
plan to have surgery.
are pregnant or plan to become pregnant. It is not known if Halobetasol Propionate Topical Foam will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if halobetasol propionate passes into your breast milk. If you use Halobetasol Propionate Topical Foam and breastfeed, do not apply Halobetasol Propionate Topical Foam to your nipple or areola to avoid getting Halobetasol Propionate Topical Foam into your baby's mouth.

have a skin infection. You may need medicine to treat the skin infection before using Halobetasol Propionate Topical Foam.

have diabetes.

have adrenal gland problems.

have liver problems.

plan to have surgery.

are pregnant or plan to become pregnant. It is not known if Halobetasol Propionate Topical Foam will harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if halobetasol propionate passes into your breast milk. If you use Halobetasol Propionate Topical Foam and breastfeed, do not apply Halobetasol Propionate Topical Foam to your nipple or areola to avoid getting Halobetasol Propionate Topical Foam into your baby's mouth.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth, or injection, or use other products on your skin that contain corticosteroid.

How should I use Halobetasol Propionate Topical Foam?

See the “Instructions for Use” for detailed information about the right way to apply Halobetasol Propionate Topical Foam.

Use Halobetasol Propionate Topical Foam exactly as your healthcare provider tells you to use it.
Apply a thin layer of Halobetasol Propionate Topical Foam to the affected skin areas 2 times each day.
You should not use more than 50 grams of Halobetasol Propionate Topical Foam in 1 week.
Avoid using Halobetasol Propionate Topical Foam on your face, underarms (armpits), or groin areas.
Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.
Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with Halobetasol Propionate Topical Foam.
Do not use Halobetasol Propionate Topical Foam longer than 2 continuous weeks unless advised to do so by your prescriber.
Wash your hands after using Halobetasol Propionate Topical Foam unless you are using the medicine to treat your hands.

Apply a thin layer of Halobetasol Propionate Topical Foam to the affected skin areas 2 times each day.

You should not use more than 50 grams of Halobetasol Propionate Topical Foam in 1 week.

Avoid using Halobetasol Propionate Topical Foam on your face, underarms (armpits), or groin areas.

Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.

Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with Halobetasol Propionate Topical Foam.

Do not use Halobetasol Propionate Topical Foam longer than 2 continuous weeks unless advised to do so by your prescriber.

Wash your hands after using Halobetasol Propionate Topical Foam unless you are using the medicine to treat your hands.

What should I avoid while using Halobetasol Propionate Topical Foam?

Halobetasol Propionate Topical Foam is flammable. Avoid heat, flame, or smoking during and right after applying Halobetasol Propionate Topical Foam to your skin.

What are the possible side effects of Halobetasol Propionate Topical Foam?

Halobetasol Propionate Topical Foam may cause serious side effects, including:

Halobetasol Propionate Topical Foam can pass through your skin. Too much Halobetasol Propionate Topical Foam passing through your skin can cause adrenal glands to stop working.
Cushing's syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol.
High blood sugar (hyperglycemia).
Vision problems. Halobetasol Propionate Topical Foam may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Halobetasol Propionate Topical Foam.
Skin reactions at the treated skin site. Tell your healthcare provider if you get any skin reactions or skin infections.
Effects on growth and weight in children.

Cushing's syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol.

High blood sugar (hyperglycemia).

Vision problems. Halobetasol Propionate Topical Foam may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Halobetasol Propionate Topical Foam.

Skin reactions at the treated skin site. Tell your healthcare provider if you get any skin reactions or skin infections.

Effects on growth and weight in children.

Your healthcare provider may do certain blood tests to check for side effects.

The most common side effect of Halobetasol Propionate Topical Foam is mild to moderate pain at the treated site.

These are not all of the possible side effects of Halobetasol Propionate Topical Foam.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Halobetasol Propionate Topical Foam?

Store Halobetasol Propionate Topical Foam at room temperature between 68°F to 77°F (20°C to 25°C).
Do not puncture or burn Halobetasol Propionate Topical Foam can.
Do not store Halobetasol Propionate Topical Foam next to heat or store at temperatures above 120°F (49°C).
Do not freeze Halobetasol Propionate Topical Foam.

Do not puncture or burn Halobetasol Propionate Topical Foam can.

Do not store Halobetasol Propionate Topical Foam next to heat or store at temperatures above 120°F (49°C).

Do not freeze Halobetasol Propionate Topical Foam.

Keep Halobetasol Propionate Topical Foam and all medicines out of the reach of children.

General information about the safe and effective use of Halobetasol Propionate Topical Foam.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Halobetasol Propionate Topical Foam for a condition for which it was not prescribed. Do not give Halobetasol Propionate Topical Foam to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Halobetasol Propionate Topical Foam that is written for health professionals.

What are the ingredients in Halobetasol Propionate Topical Foam?

Active ingredient: halobetasol propionate

Inactive ingredients: alcohol (dehydrated), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol, and purified water. Halobetasol Propionate Topical Foam is dispensed from an aluminum can pressurized with a hydrocarbon propellant containing isobutane and propane.

Distributed by:

Mayne Pharma

Raleigh, NC 27609

For more information, call 1-866-634-9120

Revised: 08/2023

Instructions for Use

INSTRUCTIONS FOR USE

Halobetasol Propionate (hal-oh-BAY-ta-sol PRO-pee-oh-nate)

Topical Foam, 0.05%

Read the Patient Information and Instructions for Use before you use Halobetasol Propionate Topical Foam.

Important information: Halobetasol Propionate Topical Foam is for skin use only. Do not get Halobetasol Propionate Topical Foam in your mouth, eyes, or vagina.

Parts of the Halobetasol Propionate Topical Foam can:
Step 1: Before applying Halobetasol Propionate Topical Foam for the first time, remove cap and break the small tab at the base of the actuator by gently pushing the actuator away from the tab as shown. Do not break the hinge on the actuator.
Step 2: Shake the can well before use.
Step 3: Turn the can completely upside down.
Step 4: Press down on the actuator to dispense a small amount of the foam into the palm of your hand.
Step 5: Apply a thin layer of Halobetasol Propionate Topical Foam to the affected skin area. Gently rub Halobetasol Propionate Topical Foam into the affected skin until the foam disappears. Repeat Steps 4 and 5 to all the affected areas as prescribed by your healthcare provider.
Step 6: After applying Halobetasol Propionate Topical Foam, put the cap back on the can.
Step 7: Wash your hands after applying Halobetasol Propionate Topical Foam unless you are using the medicine to treat your hands.