Ultravate X Cream

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.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Rinse with water if this medicine gets in your eyes.

Avoid applying this medicine to your face, underarms, or groin area unless your doctor tells you to.

Do not use halobetasol topical to treat any skin condition that has not been checked by your doctor.

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

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Tell your doctor if you have:

• weight gain (especially in your face or your upper back and torso);

• slow wound healing, thinning skin, increased body hair;

• irregular menstrual periods, changes in sexual function; or

• muscle weakness, tired feeling, depression, anxiety, feeling irritable.

Common side effects may include:

• stinging or burning where the medicine was applied.

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.

It is not likely that other drugs you take orally or inject will have an effect on topically applied halobetasol. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Ultravate® (halobetasol propionate) Cream, 0.05% contains halobetasol propionate, a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agent.

Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate, C25H31ClF2O5. It has the following structural formula:

Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water.

Each gram of Ultravate Cream contains 0.5 mg/g of halobetasol propionate in a cream base of cetyl alcohol, glycerin, isopropyl isostearate, isopropyl palmitate, steareth-21, diazolidinyl urea, methylchloroisothiazolinone, (and) methylisothiazolinone and water.

Ultravate Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

In controlled clinical trials, the most frequent adverse events reported for Ultravate Cream included stinging, burning or itching in 4.4% of the patients. Less frequently reported adverse reactions were dry skin, erythema, skin atrophy, leukoderma, vesicles and rash.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as Ultravate Cream. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.