Dermasorb AF

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Clioquinol and hydrocortisone topical is for use only on the skin. Do not use this medicine in open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medication gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Wash your hands before and after each application, unless you are using clioquinol and hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medicine near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover the treated skin area unless your doctor tells you to. If you are treating the diaper area, do not use plastic pants or tight- fitting diapers. Covering the skin that is treated with clioquinol and hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Call your doctor if your symptoms do not improve, or if they get worse while using clioquinol and hydrocortisone topical.

Do not share this medication with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

An overdose of topical hydrocortisone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

You should not use this medicine if you are allergic to clioquinol, hydrocortisone, iodoquinol or hydroxyquinoline.

To make sure clioquinol and hydrocortisone is safe for you, tell your doctor if you have:

• active or chronic infections (other than the skin infection you are treating with this medicine);

• diabetes;

• allergies;

• weak immune system (caused by disease or by using certain medicine);

• blood circulation problems;

• glaucoma, cataracts;

• a thyroid disorder;

• tuberculosis of the skin or

• herpes infection of the eyes.

FDA pregnancy category B. Clioquinol and hydrocortisone topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether clioquinol and hydrocortisone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects.

Clioquinol and hydrocortisone should not be used on a child younger than 2 years old.

• Store in the original container at room temperature.
• Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Iodochlorhydroxyquin (Clioquinol) is an antifungal agent and a member of a family of drugs called hydroxyquinolines. Chemically, Iodochlorhydroxyquin is 5-chloro-7-iodo-quinolin-8-ol. Its structural formula is:

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3,20-dione, 11, 17,21-trihydroxy, (11β)- Its structural formula is:

Each gram of Dermasorb AF contains 5mg Hydrocortisone USP and 30mg Iodochlorhydroxyquin USP in a cream base consisting of water, cetyl alcohol, stearyl alcohol, cetyl palmitate, sorbic acid, sodium lauryl sulfate, glycerin, and polysorbate-80.

Iodochlorhydroxyquin is a broad-spectrum antibacterial and antifungal. Its precise mechanism of action is unknown. Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and some evidence suggests a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Risk-benefit should be considered when the following medical problems exist:

• Intolerance to iodochlorhydroxyquin, hydrocortisone, chloroxine, iodine, iodine-containing preparations, or related compounds

• Herpes simplex, vaccinia, eczema vaccinia, varicella, or other viral infections of the skin

The following tests may be helpful in evaluating HPA axis suppression:

       Urinary free cortisol test

       ACTH stimulation test

Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their use in pregnant women has not been absolutely established. Use of large amounts or for prolonged periods of time is not recommended since systemic absorption may occur. In laboratory animals, increases in incidence of fetal abnormalities have been associated with exposure of gestating females to topical corticosteroids, in some cases at rather low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Therefore, drugs of this class should not be used extensively on pregnant patients in large amounts or for prolonged periods of time.

Apply a thin layer to the affected area 3 or 4 times daily.