Cloderm cream is a medium-potency corticosteroid that contains clocortolone pivalate 0.1% which may be used to treat inflammation and itching caused by eczema, dermatitis, psoriasis, or other skin conditions that respond to steroid medication.

It is a class C corticosteroid and contains no lanolin, propylene glycol, or added fragrance, and has a low risk for allergic contact dermatitis.

Cloderm was approved on August 22, 1977.

Use care when using on large areas of skin. Do not use it to treat any other skin condition other than the one your doctor has prescribed it for.

Cloderm cream contains clocortolone pivalate 0.1% which can be absorbed through the skin into the bloodstream and cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency, including Cushing’s syndrome, hyperglycemia, and glucosuria. Do not use large quantities for long periods. Periodic monitoring for HPA suppression may be required.

Occlusive dressings should not be used unless under the advice of the doctor because these increase the risk of side effects.

Report any side effects to your doctor.

Before taking this medicine

You should not use Cloderm cream if you are allergic to it or any of its inactive ingredients.

Tell your doctor if you have ever had:

• any type of skin infection
• cataracts or glaucoma
• diabetes
• a skin reaction to any steroid medicine
• thinning of the skin after applying a corticosteroid product
• liver disease or
• an adrenal gland disorder.

Topical corticosteroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Children may be more susceptible to systemic toxicity because their skin absorbs proportionally larger amounts of topical corticosteroids.

It is not known whether Cloderm cream will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use the cream, use only a small amount and for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to use Cloderm cream, use only a small amount and for the shortest time possible. Do not apply to the breasts.

Apply the cream thinly to the affected areas three times daily. Rub in gently, then wash your hands after use, unless your hands are being treated.

Do not bandage, cover, or wrap your skin unless your doctor has told you to do so. A doctor may advise people with psoriasis or hard-to-treat conditions to use occlusive dressings. If an infection develops with the use of an occlusive dressing, a topical antimicrobial cream may be necessary.

Discontinue use if irritation develops.

Apply only to the skin. Do not take by mouth, apply near your eyes, or insert it.

You should not use Cloderm cream if you are allergic to it or any of its inactive ingredients.

Tell your doctor if you have ever had:

• any type of skin infection
• cataracts or glaucoma
• diabetes
• a skin reaction to any steroid medicine
• thinning of the skin after applying a corticosteroid product
• liver disease or
• an adrenal gland disorder.

Topical corticosteroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Children may be more susceptible to systemic toxicity because their skin absorbs proportionally larger amounts of topical corticosteroids.

It is not known whether Cloderm cream will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use the cream, use only a small amount and for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to use Cloderm cream, use only a small amount and for the shortest time possible. Do not apply to the breasts.

The most common side effects of Cloderm cream include itching, burning, stinging, and irritation at the treated site. Other side effects reported with topical corticosteroids include:

• acne
• allergic contact dermatitis
• burning, itching, swelling, or irritation of treated skin
• dry or cracking skin
• redness or crusting around your hair follicles
• spider veins
• stretch marks, thinning skin
• rash or hives.

Possible signs that you may be absorbing this medicine through your skin include weight gain in your face and shoulders, increased body hair, tiredness, mood changes, menstrual changes, and sexual changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Creams applied to the skin such as Cloderm are not likely to be affected by other drugs you use. But you should not use Cloderm with other topical or oral corticosteroids unless directed to by your doctor, because they may have an additive effect.

Tell your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.