Ultravate PAC Ointment

Generic Name: Halobetasol Ointment and Ammonium Lactate (HAL-oh-BAY-ta-sol/a-MOE-nee-um LAK-tate)Brand Name: Ultravate PAC

Ultravate PAC Ointment is used for:

Treating inflammation and itching caused by certain skin conditions. It may also be used for other conditions as determined by your doctor.

Ultravate PAC Ointment is a kit that contains a topical corticosteroid and a humectant. The corticosteroid reduces skin inflammation (redness, swelling, itching, and irritation). The humectant moisturizes and softens the skin.

Do NOT use Ultravate PAC Ointment if:

  • you are allergic to any ingredient in Ultravate PAC Ointment

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ultravate PAC Ointment:

Some medical conditions may interact with Ultravate PAC Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines or other substances
  • if you have rosacea, any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin
  • if you have had a recent vaccination; have measles, tuberculosis (TB), chickenpox, or shingles; or have had a positive TB test
  • if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Ultravate PAC Ointment. However, no specific interactions with Ultravate PAC Ointment are known at this time.

Ask your health care provider if Ultravate PAC Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ultravate PAC Ointment:

Use Ultravate PAC Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • To use the halobetasol ointment: Apply a small amount of medicine to the affected area. Gently rub it in until it is evenly distributed. Wash your hands after you apply Ultravate PAC Ointment, unless your hands are part of the treated area.
  • Do not bandage or cover the treated skin area unless directed by your doctor.
  • To use the ammonium lactate lotion: Shake well before each use. Apply to dry skin and rub in completely 2 times daily or as directed by your doctor. Wash your hands right away after you apply Ultravate PAC Ointment, unless your hands are a part of the treated area.
  • If you miss a dose of Ultravate PAC Ointment, apply it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Ultravate PAC Ointment.

Important safety information:

  • Ultravate PAC Ointment is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.
  • Do not use halobetasol on the face, in the groin area, or under the armpits.
  • Do NOT use more than the recommended dose or use for longer than 2 weeks without checking with your doctor.
  • If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.
  • Talk with your doctor before you receive any vaccines while you are using halobetasol.
  • Do not use Ultravate PAC Ointment for other skin conditions at a later time.
  • Talk with your doctor before you use any other medicines or cleansers on your skin.
  • Overuse of topical products may worsen your condition.
  • Ammonium lactate may cause temporary stinging or burning when applied to cracked or scraped skin (eg, after shaving).
  • Ammonium lactate may cause increased sensitivity to the sun. Avoid the sun, sunlamps, or tanning booths until you know how you react to Ultravate PAC Ointment. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Ultravate PAC Ointment has a corticosteroid in it. Before you start any new prescription or nonprescription medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Tell your doctor or dentist that you take Ultravate PAC Ointment before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including ACTH-stimulation test, AM plasma cortisol test, and urinary free cortisol test, may be performed while you use Ultravate PAC Ointment. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Ultravate PAC Ointment.
  • Halobetasol should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ultravate PAC Ointment while you are pregnant. It is not known if Ultravate PAC Ointment is found in breast milk after topical use. If you are or will be breast-feeding while you use Ultravate PAC Ointment, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ultravate PAC Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; itching; mild, temporary burning, irritation, peeling, redness, sensitivity, or stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Ultravate PAC Ointment; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; symptoms of high blood pressure (eg, flushing, confusion, drowsiness, increased thirst, increased urination); thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Ultravate PAC Ointment:

Store Ultravate PAC Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Ultravate PAC Ointment out of the reach of children and away from pets.

General information:

  • If you have any questions about Ultravate PAC Ointment, please talk with your doctor, pharmacist, or other health care provider.
  • Ultravate PAC Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ultravate PAC Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Ultravate PAC Concise Consumer Information (Cerner Multum)
  • Halonate Prescribing Information (FDA)