Impeklo

Impeklo lotion is a prescription corticosteroid medicine used on the skin (topical) for the relief of swelling (inflammation) and itching caused by certain skin conditions in people 18 years of age and older.

Impeklo lotion should not be used for the treatment of acne vulgaris, rosacea or red, dry itchy skin (dermatitis) around the mouth.

Impeklo lotion is not recommended in children under 18 years of age.

Important: Impeklo lotion is for use on the skin only. Do not get the lotion near or in your eyes, mouth or vagina.

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have had irritation or other skin reactions to a steroid medicine in the past.
• have a skin infection. You may need medicine to treat the skin infection before you start treatment.
• 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 Impeklo lotion can harm your unborn baby. If you use the lotion during pregnancy, use on the smallest area of skin and for the shortest time needed.
• are breastfeeding or plan to breastfeed. It is not known if Impeklo lotion passes into your breast milk. If you use the lotion while breastfeeding, use on the smallest area of skin and for the shortest time needed. Do not apply the lotion directly to the nipple and areola to avoid getting the lotion into your baby’s mouth.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Do not use other products containing corticosteroid medicine during treatment without talking to your healthcare provider first.

Impeklo lotion may cause serious side effects, including:

• Impeklo lotion can pass through your skin. Too much Impeklo lotion passing through your skin can cause your adrenal glands to stop working.
• Cushing’s syndrome, a condition that happens when the body is exposed to too much of the hormone cortisol.
• High blood sugar (hyperglycemia).
• Vision problems. Impeklo lotion may increase your chance of developing vision problems such as cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Impeklo lotion.
• 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.

The most common side effects include thinning of the skin (atrophy), widening of small veins in the skin, skin discomfort and skin dryness.

These are not all of the possible side effects.

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

See the Instructions for Use for detailed information about the right way to apply the lotion.

• Use Impeklo lotion exactly as your healthcare provider tells you to use it.
• Apply the lotion 2 times each day to the affected skin areas and rub in gently and completely.
• You should not use the lotion on your face, underarms (armpits), groin, or in areas with thinning skin (atrophy).
• Do not bandage, cover or wrap your treated area unless your healthcare provider tells you to.
• Do not use more than 50 grams of Impeklo lotion in 7 days. Do not use more than 10 pumps of the lotion at one time twice daily or 20 pumps per day for more than 7 days.
• Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment.
• Wash your hands after using Impeklo lotion.

• Store Impeklo lotion at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze Impeklo lotion.
• Keep all medicines out of reach of children and pets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Impeklo lotion for a condition for which it was not prescribed. Do not give Impeklo lotion 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 Impeklo lotion that is written for health professionals.

Active ingredient: clobetasol propionate Inactive ingredients: carbomer 1342, hypromellose, mineral oil, PEG-6 isostearate, propylene glycol, purified water and sodium hydroxide.

Step 1: Priming the Impeklo lotion pump (do this step only 1 time for each bottle).

• Remove and keep the large cap from the bottle.
• Remove and keep the small cap around the tip of the pump.
• Turn the pump counter clockwise (left) from the “lock” (Lock Position) position to the “unlock” (Unlock Position) position.
• To prime the pump, slowly push the pump top down all the way 10 times. Dispense this portion of the medicine onto a paper towel and throw it away in the trash.
• Your lotion pump is ready to use.
• Note: If you are not ready to apply the lotion, turn the pump clockwise (right) from the “unlock” (Unlock Position) position to the “lock” (Lock Position) position. Unlock the pump when you are ready to use.

Step 2: Applying Impeklo lotion to your skin.

• Push the pump top down firmly and fully to dispense the lotion into the palm of your hand or directly onto the affected skin areas. You should keep a count of how many times you push the pump down to dispense the lotion.
• Apply only enough lotion to cover the affected skin areas and rub in gently and completely. Do not push down on the pump more than 10 times each time you apply lotion or more than 20 times each day.

Step 3: After using Impeklo lotion

• Turn the pump clockwise (right) from the “unlock” (Unlock Position) position to the “lock” (Lock Position) position.
• Place the small cap back around the tip of the pump. Place the large cap over the top of the bottle.
• Wash your hands after applying the lotion.