CLODERM Cream, 0.1% is indicated for the relief of the inflammatory and itching symptoms of corticosteroid responsive skin diseases.
IMPORTANT PATIENT SAFETY INFORMATION
- CLODERM Cream is for external use only. Avoid contact with the eyes.
- Do not bandage or wrap the treated area unless directed by your healthcare provider.
- Pediatric patients: if using CLODERM Cream in the diaper area of a young child, please contact your healthcare provider before putting a tight-fitting diaper or plastic pants on the child as this may act like a bandage or wrap.
- Do not use CLODERM Cream if you are allergic to any of the ingredients in CLODERM Cream.
- If you are pregnant, planning to become pregnant, or nursing please contact your healthcare provider before using CLODERM Cream.
Children may absorb proportionally larger amounts of topical corticosteroids and may be more susceptible to side effects. As with all topical corticosteroids, too much CLODERM Cream passing through your skin can cause your adrenal glands to stop working. Your healthcare provider may do blood tests to check for adrenal gland problems.
The most common side effects of CLODERM Cream include burning, itching, irritation, dryness, inflamed hair follicles (folliculitis), excessive hair growth, acne-like eruptions, and thinning of the skin with prolonged use.
These are not all the possible side effects of CLODERM Cream. For more information, ask your healthcare provider or pharmacist.
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.