INDICATION AND IMPORTANT SAFETY INFORMATION
CLODERM Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The most common adverse events with CLODERM Cream include burning, itching, irritation, dryness, and folliculitis. CLODERM Cream is contraindicated in patients who are hypersensitive to any of the ingredients of this product. As with all topical corticosteroids, systemic absorption can produce reversible HPA-axis suppression.
You are encouraged to report negative side effects of prescription drugs. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088 (1-800-332-1088) or online at http://www.fda.gov/Safety/MedWatch
Please see Full Prescribing Information.
References: 1. Cloderm [package insert]. Princeton, NJ: Promius Pharma, LLC; 2017. 2. Rosenthal AL. Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. Cutis. 1980;25(1):96-98. 3. Del Rosso JQ, Kircik L. A comprehensive review of clocortolone pivalate 0.1% cream: structural development, formulation characteristics, and studies supporting treatment of corticosteroid-responsive dermatoses. J Clin Aesthet Dermatol. 2012;5(7):20-24. 4. Kircik LH. A study to assess the occlusivity and moisturization potential of three topical corticosteroid products using the skin trauma after razor shaving (STARS) bioassay. J Drugs Dermatol. 2014;13(5):582-585. 5. Bikowski J, Pillai R, Shroot B. The position not the presence of the halogen in corticosteroids influences potency and side effects. J Drugs Dermatol. 2006;5(2):125-130. 6. Katz M, Gans EH. Topical corticosteroids, structure-activity and the glucocorticoid receptor: discovery and development—a process of ‘‘planned serendipity.’’ J Pharm Sci. 2008; 97 (8): 2936-2947. 7. Jacob SE, Steele T. Corticosteroid classes: A quick reference guide including patch test substances and cross-reactivity. J Am Acad Dermatol. 2006;54(4):723-727. 8. Nierman MM. Safety and efficacy of clocortolone pivalate 0.1 percent cream in the treatment of atopic dermatitis, contact dermatitis, and seborrheic dermatitis. Cutis. 1981;27(6):670-671. 9. Kircik LH, Del Rosso JQ. The treatment of inflammatory facial dermatoses with topical corticosteroids: focus on clocortolone pivalate 0.1% cream. J Drugs Dermatol. 2012;11(10):1194-1198.