HOW SUPPLIED
CLOBEX™ Lotion, 0.05% is supplied in the following sizes:
1 fl. oz./30 mL NDC 0299-3848-01 high density polyethylene bottles.
2 fl. oz./59 mL NDC 0299-3848-02 high density polyethylene bottles.
Store at controlled room temperature 68° to 77°F (20°-25°C). Protect from freezing.
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Manufactured by:
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA
GALDERMA is a registered trademark.
325054-0703
Revised: July 2003
CLOBEX™
(clobetasol propionate) Lotion, 0.05%
PATIENT INFORMATION
For External Use Only
Not for Ophthalmic (Eye) Use
Read the Patient Information that comes with CLOBEX™ (KLO-bex) Lotion before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
What is CLOBEX™ Lotion?
CLOBEX™ Lotion is a medicine called a topical (skin use only) corticosteroid. It is used for a short time to reduce the inflammation and itching of:
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Moderate to severe skin conditions (atopic dermatitis and other skin problems)
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Moderate to severe plaque psoriasis
CLOBEX™ Lotion is a super-high potent (very strong) topical corticosteroid. It is very important that you use CLOBEX™ Lotion only as directed, in order to avoid serious side effects.
Who should not use CLOBEX™ Lotion?
Do not use CLOBEX™ Lotion if you are allergic to any of its ingredients, or to any other corticosteroid. The active ingredient is clobetasol propionate. See the end of this leaflet for the complete list of other ingredients in CLOBEX™ Lotion. Ask your doctor or pharmacist if you need a list of other corticosteroids.
CLOBEX™ Lotion is not recommended for use on anyone younger than 18 years of age. CLOBEX™ Lotion has not been studied in children under 12 years old. Children have smaller body sizes and have a higher chance of side effects.
What should I tell my doctor before using CLOBEX™ Lotion?
Tell your doctor:
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if you are pregnant, think you are pregnant or plan to be pregnant. Talk with your doctor before using CLOBEX™ Lotion or if you are already using CLOBEX™ Lotion, as it is not known if CLOBEX™ Lotion can harm your unborn child.
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if you are breastfeeding. It is not known if CLOBEX™ Lotion passes into your milk.
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if you think you have a skin infection. You may need another medicine to treat the skin infection before you use CLOBEX™ Lotion.
Tell your doctor about all the other medicines and skin products you use, including prescription and non-prescription medicines, cosmetics, vitamins, and herbal supplements. Some medicines can cause serious side effects if used while you are using CLOBEX™ Lotion.
How should I use CLOBEX™ Lotion?
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Use CLOBEX™ Lotion exactly as directed by your doctor. CLOBEX™ Lotion is for skin use only.
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Apply CLOBEX™ Lotion twice a day, once in the morning and once at night, or as directed by your doctor.
Use only enough to cover the affected areas. Do not apply CLOBEX™ Lotion to your face, neck, groin or armpits. Do not get CLOBEX™ Lotion on your lips or in or near your eyes.
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Make sure your skin is clean and dry before applying CLOBEX™ Lotion.
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Turn the bottle of CLOBEX™ Lotion upside down. Pour a small amount, less than 1 teaspoonful of CLOBEX™ Lotion onto your fingertips, or directly on your affected skin area. Gently, rub the CLOBEX™ Lotion into your affected skin area, until the lotion disappears.
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Wash your hands after using CLOBEX™ Lotion.
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If you forget to apply CLOBEX™ Lotion at the scheduled time, use it as soon as you remember. Then go back to your regular schedule. If it is about time for your next dose, apply just that 1 dose, and continue with your normal application schedule. Do not try to make up for the missed dose. If you miss several doses, tell your doctor.
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Throw away unused CLOBEX™ Lotion.
What should I avoid while using CLOBEX™ Lotion?
Do not do the following while using CLOBEX™ Lotion.
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Do not get CLOBEX™ Lotion on your face, lips, or in or near your eyes because this might cause irritation. If you do, use a lot of water to rinse the CLOBEX™ Lotion off your face, lips, or out of your eyes. If your eyes keep stinging after rinsing them well with water, call your doctor right away.
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Do not apply CLOBEX™ Lotion to your groin or armpits.
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Do not bandage or cover your treated areas unless your doctor tells you to do so.
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Do not wear tight fitting clothes over your treated skin areas.
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Do not use CLOBEX™ Lotion any longer than 2 weeks (14 days) for moderate to severe conditions (atopic dermatitis and other skin problems).
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Do not use CLOBEX™ Lotion any longer than an extra 2 weeks (4 weeks total) for psoriasis on a small area of your body (less than 10 percent of your body surface area) that is not much better after the first 2 weeks of treatment.
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Do not use more than 50 grams (50 mL or 1.75 fluid ounces) of CLOBEX™ Lotion a week. CLOBEX™ Lotion comes in 2 different size bottles, a 1-ounce and a 2-ounce bottle.
What are the possible side effects of CLOBEX™ Lotion?
CLOBEX™ Lotion can pass through your skin. Too much CLOBEX™ Lotion passing through your skin can shut down your adrenal glands. This usually happens if you use too much CLOBEX™ Lotion, or you use it for too long. If this happens, your adrenal glands may not start working immediately once you stop using CLOBEX™ Lotion. Shutting down of the adrenal glands can cause nausea, vomiting, fever, low blood pressure, heart attack, and even death because your body cannot respond to any stress or illness.
Your doctor may do special blood and urine tests to check your adrenal gland function while you are using CLOBEX™ Lotion.
Other possible side effects with CLOBEX™ Lotion include mild burning, stinging, itching, redness, irritation, and dry skin. Also, thinning of the skin, widening of small blood vessels in the skin, and skin discomfort at the site of application may happen. Sometimes your condition will get worse with use of CLOBEX™ Lotion.
If you are ill or injured, or going to have surgery, tell your doctor that you are using CLOBEX™ Lotion.
Tell your doctor if you:
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are going to have surgery
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get sick or don't feel right. Call your doctor right away.
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have irritation of the treated skin area that does not go away.
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have any unusual effects that you do not understand.
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have affected areas that do not seem to be getting better after 2 weeks of using CLOBEX™ Lotion.
These are not all the possible side effects of CLOBEX™ Lotion. For more information, ask your doctor or pharmacist.
General information about the safe and effective use of CLOBEX™ Lotion.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use CLOBEX™ Lotion for a condition for which it was not prescribed. Do not give CLOBEX™ Lotion to other people, even if they have the same symptoms you have. It may harm them. Keep CLOBEX™ Lotion and all medicines out of reach of children.
This leaflet summarizes the most important information about CLOBEX™ Lotion. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLOBEX™ Lotion that is written for health professionals. What are the ingredients of CLOBEX™ Lotion?
Active Ingredient: clobetasol propionate
Inactive Ingredients: hydroxypropyl methylcellulose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.
Rx only
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Manufactured by:
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA
GALDERMA is a registered trademark.
325054-0703
Revised: July 2003
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