Important Safety Information for Clobex ® (clobetasol propionate) Lotion, %
Clobex ® (clobetasol propionate) Lotion, %, is not recommended for anyone younger than 18 years of age.
Clobex ® Lotion is indicated to treat steroid-responsive dermatoses. Treatment of steroid responsive dermatoses (eczema, dermatitis) should be limited to 2 weeks. Use only as directed by your physician, and do not apply to your face, underarms, or groin and avoid contact with your eyes and lips.
The total dosage should not exceed 50 g (50 mL or fl oz) per week. You should use Clobex ® Lotion only for the minimum period necessary to achieve desired results. In clinical trials, patients reported burning/stinging, skin dryness, irritation, redness, itching, skin thinning and widening of blood vessels. Because too much Lotion passing through your skin may affect your adrenal glands, do not use more than prescribed and stop using the product if you experience nausea, vomiting, fever or low blood pressure, and call you doctor. If you are pregnant, trying to get pregnant or nursing, speak to your doctor before using Clobex ® Lotion.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit /medwatch , or call 1-800-FDA-1088 (1-800-332-1088).
The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, , 25, and 50 mcg/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than mcg/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles. The female reproductive NOEL was mcg/kg/day (ratio of animal dose to proposed human dose of on a mg/m 2 /day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.
Read the Instructions for Use that comes with CLOBEX Shampoo before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
How to apply CLOBEX Shampoo to your scalp:
Your hair should be dry when you apply CLOBEX Shampoo to your scalp.
Do not get CLOBEX Shampoo on your face, in your eyes or on your lips. If CLOBEX Shampoo does get on these areas, rinse well with water.
Step 1: To apply CLOBEX Shampoo to your scalp, part your hair at the area where it is to be applied.
Step 2: Hold the bottle of CLOBEX Shampoo over the affected area. Gently squeeze the bottle and apply a small amount of shampoo to the affected area.
Step 3: Gently rub CLOBEX Shampoo into the affected area so that only the affected area is covered with a thin, even layer of CLOBEX Shampoo.
Step 4: Repeat Steps 1 through 3 to apply CLOBEX Shampoo to other affected areas on your scalp as instructed by your doctor.
Step 5: Wash your hands after applying CLOBEX Shampoo.
Step 6: Leave CLOBEX Shampoo on your scalp for 15 minutes. You should not bandage or cover your head with a shower cap, bathing cap, or a towel while CLOBEX Shampoo is on your scalp, unless your doctor tells you to.
Step 7: After 15 minutes have passed, wet your hair with water. Lather and rinse your hair and scalp completely. Rinse any other parts of your body that come into contact with CLOBEX Shampoo, such as your hands, face, neck and shoulders.
No other shampoo is needed, but you may wash your hair with a non-medicated shampoo after using CLOBEX Shampoo.
This Patient Information and Instructions for Use have been approved by the . Food and Drug Administration.
GALDERMA LABORATORIES, .
Fort Worth, Texas 76177 USA
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA