Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5fluoromethyl carbothiolate grouping. This transformation occurs in 1 metabolic step to produce the inactive 17β-carboxylic acid metabolite, the only known metabolite detected in man. This metabolite has approximately 2000 times less affinity than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies. Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.
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
Clobetasol propionate at concentrations up to % did not increase the rate of formation of ultra violet light-induced skin tumors when topically applied to hairless mice 5 days per week for a period of 40 weeks.
Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test
The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, , 25, and 50 μg/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 μg/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 with fluid. The female reproductive NOEL was μg/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.
Semi-crystalline cellulose polymers react at pyrolysis temperatures (350–600 °C) in a few seconds; this transformation has been shown to occur via a solid-to-liquid-to-vapor transition, with the liquid (called intermediate liquid cellulose or molten cellulose ) existing for only a fraction of a second.  Glycosidic bond cleavage produces short cellulose chains of two-to-seven monomers comprising the melt. Vapor bubbling of intermediate liquid cellulose produces aerosols , which consist of short chain anhydro-oligomers derived from the melt. 
Semi-crystalline cellulose polymers react at pyrolysis temperatures (350–600 °C) in a few seconds; this transformation has been shown to occur via a solid-to-liquid-to-vapor transition, with the liquid (called intermediate liquid cellulose or molten cellulose ) existing for only a fraction of a second.  Glycosidic bond cleavage produces short cellulose chains of two-to-seven monomers comprising the melt. Vapor bubbling of intermediate liquid cellulose produces aerosols , which consist of short chain anhydro-oligomers derived from the melt.