CLOBEX® (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a
synthetic fluorinated corticosteroid, for topical dermatologic use. The corticosteroids constitute a
class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Patients using topical corticosteroids should receive the following information and instructions:
This medication is to be used as directed by the physician and should not be used longer than
the prescribed time period.
This medication should not be used for any disorder other than that for which it was prescribed.
The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.
Patients should wash their hands after applying the medication.
Patients should report any signs of local or systemic adverse reactions to the physician.
Patients should inform their physicians that they are using CLOBEX® (clobetasol propionate)
Lotion, 0.05% if surgery is contemplated.
This medication is for external use only. It should not be used on the face, underarms, or
groin area, and avoid contact with the eyes and lips.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no
improvement is seen within 2 weeks, contact the physician.
Patients should be informed to not use more than 50 g (50 mL or 1.75 fl. oz.) per week of
CLOBEX® Lotion, 0.05%
Directions:
Use CLOBEX® Lotion exactly as directed by your doctor. CLOBEX® Lotion is for skin use only.
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.
Make sure your skin is clean and dry before applying CLOBEX® Lotion.
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.
Wash your hands after using CLOBEX® Lotion.
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.
Throw away unused CLOBEX® Lotion.
Side Effects: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.
Warnings:CLOBEX® Lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis,
and should not be used on the face, groin, or axillae. Do not do the following while using CLOBEX® Lotion:
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.
Do not apply CLOBEX® Lotion to your groin or armpits.
Do not bandage or cover your treated areas unless your doctor tells you to do so.
Do not wear tight fitting clothes over your treated skin areas.
Do not use CLOBEX® Lotion any longer than 2 weeks (14 days) for moderate to severe conditions
(atopic dermatitis and other skin problems).
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.
Do not use more than 50 grams (50 mL or 1.75 fluid ounces) of CLOBEX® Lotion a week. CLOBEX®
Lotion comes in 3 different size bottles, a 1-ounce, a 2-ounce and a 4-ounce bottle.
