Ultravate PAC

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Use this medication on the skin only. Do not use it on the face, groin or underarms unless directed to do so by your doctor. Before applying the medication, clean and dry the affected area. Apply a thin film of the medication to the affected area and gently rub in, one to two times daily or as directed by your doctor. Do not wrap, cover or bandage the area unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants. After applying the medication, wash your hands unless you are using this medication to treat the hands. If applying this medication near the eyes, avoid getting it in the eyes as this may worsen or cause glaucoma. Also avoid getting this medication in the nose or mouth. Use this medication only for the condition prescribed. Do not use it for longer than two weeks in a row unless directed to do so by your doctor. If your condition worsens or does not improve in 2 weeks, contact your doctor.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: oral corticosteroids (e.g., prednisone), drugs that suppress the immune system (e.g., cyclosporine). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases. Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details. Inform all your doctors you use (or have used) this medication.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medication may be harmful if swallowed.

Before using halobetasol, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, immune system problems, certain skin conditions (rosacea, perioral dermatitis). Do not use if there is an infection or sore present in the area to be treated. Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Children may be more sensitive to the effects of too much corticosteroid medication. Though it is very unlikely to occur with corticosteroids applied to the skin, this medication may temporarily slow down a child's rate of growth if used for long periods. However, it will probably not affect final adult height. Monitor your child's height periodically. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug, when applied to the skin, passes into breast milk. Other medications in this class, when taken by mouth, pass into breast milk. Consult your doctor before breast-feeding.

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Burning, stinging, itching, dryness or redness may occur when first applied to the skin. This should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, excessive hair growth, "hair bumps" (folliculitis). Skin infections can become worse when using this medication. Notify your doctor promptly if redness, swelling or irritation does not improve. Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time or over large areas of the skin. Tell your doctor immediately if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.