Clodan (Clobetasol propionate): Uses, Side Effects and Dosage

What is Clodan^® (clobetasol propionate) Shampoo, 0.05%?

• Clodan^® Shampoo is a prescription corticosteroid medicine used to treat adults with moderate to severe forms of scalp psoriasis. Clodan^® Shampoo is for use on the scalp only (topical).
• Clodan^® Shampoo should be used for the shortest amount of time needed to treat your scalp psoriasis.
• You should not use Clodan^® Shampoo for longer than 4 weeks in a row.
• You should not use more than 50 mL (1.75 fluid ounces) of Clodan^® Shampoo in one week.

You should not use Clodan^® (clobetasol propionate) Shampoo, 0.05%:

• on your face, underarms (armpits) or groin areas. Avoid getting Clodan^® Shampoo in your eyes or on your lips.

Clodan^® Shampoo should not be used in children under 18 years of age.

What should I tell my doctor before using Clodan^® (clobetasol propionate) Shampoo, 0.05%?

Before you use Clodan^® Shampoo, tell your doctor if you:

• have a scalp infection. You may need medicine to treat the scalp infection before you use Clodan^® Shampoo.
• have any open sores or cuts on your scalp
• plan to have surgery
• have acne vulgaris, rosacea, or a rash around your mouth (perioral dermatitis)
• have any other medical conditions

• are pregnant or plan to become pregnant. It is not known if Clodan^® Shampoo can harm your unborn baby.

• are breast-feeding or plan to breast-feed. It is not known if Clodan^® Shampoo passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Clodan^® Shampoo.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using Clodan^® Shampoo. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist if you get a new medicine.

How should I use Clodan^® (clobetasol propionate) Shampoo, 0.05%?

• Use Clodan^® Shampoo exactly as your doctor tells you to use it.
• Your doctor should tell you how much Clodan^® Shampoo to use and where to apply it.
• Clodan^® Shampoo is for use on your scalp only (topical).
• Apply Clodan^® Shampoo on affected areas of your scalp one time each day.
• Use only enough Clodan^® Shampoo to cover the affected areas of your scalp.
• Do not use Clodan^® Shampoo on your face, groin, or underarms. Avoid getting Clodan^® Shampoo in your eyes or on your lips.
• Do not wet your hair before using Clodan^® Shampoo.
• If Clodan^® Shampoo gets on any part of your body other than your scalp, rinse the area well with water.
• You should not bandage or cover your head with a shower cap, bathing cap, or a towel, while Clodan^® Shampoo is on your scalp, unless your doctor tells you to.
• Tell your doctor if your scalp condition is not getting better after 4 weeks of using Clodan^® Shampoo. You should not use Clodan^® Shampoo for more than 4 weeks unless your doctor tells you to.

See the "Instructions for Use" at the end of the Patient Information for detailed information about the right way to use Clodan^® Shampoo.

What are the possible side effects of Clodan^® (clobetasol propionate) Shampoo, 0.05%?

Clodan^® Shampoo can pass through your skin. Too much Clodan^® Shampoo passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working.

The most common side effects of Clodan^® (clobetasol propionate) Shampoo, 0.05% include:

• burning or stinging at the site of application
• itching
• swelling
• inflamed hair follicle
• acne
• dry, itchy and reddened skin
• hair loss
• rash or hives
• thinning of the skin
• widening of small blood vessels in the skin

If you go to another doctor for illness, injury or surgery, tell that doctor that you are using Clodan^® Shampoo.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Clodan^® (clobetasol propionate) Shampoo, 0.05%. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512.

How should I store Clodan^® (clobetasol propionate) Shampoo, 0.05%?

• Store Clodan^® Shampoo at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the Clodan^® Shampoo bottle tightly closed.

Keep Clodan^® Shampoo and all medicines out of the reach of children.

General information about Clodan^® (clobetasol propionate) Shampoo, 0.05%

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Clodan^® Shampoo for a condition for which it was not prescribed. Do not give Clodan^® Shampoo to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Clodan^® Shampoo. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clodan^® Shampoo that is written for health professionals.

What are the ingredients in Clodan^® (clobetasol propionate) Shampoo, 0.05%?

Active ingredient: clobetasol propionate

Inactive ingredients (shampoo base): alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate.

Instructions for Use

Clodan^® (clobetasol propionate) Shampoo, 0.05%

Read the Instructions for Use that comes with Clodan^® (clobetasol propionate) Shampoo, 0.05% 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 Clodan^® Shampoo to your scalp:

Your hair should be dry when you apply Clodan^® Shampoo to your scalp.

Do not get Clodan^® Shampoo on your face, in your eyes or on your lips. If Clodan^® Shampoo does get on these areas, rinse well with water.

Step 1: To apply Clodan^® Shampoo to your scalp, part your hair at the area where it is to be applied.

Step 2: Hold the bottle of Clodan^® Shampoo over the affected area. Gently squeeze the bottle and apply a small amount of shampoo to the affected area.

Step 3: Gently rub Clodan^® Shampoo into the affected area so that only the affected area is covered with a thin, even layer of Clodan^® Shampoo.

Step 4: Repeat Steps 1 through 3 to apply Clodan^® Shampoo to other affected areas on your scalp as instructed by your doctor.

Step 5: Wash your hands after applying Clodan^® Shampoo.

Step 6: Leave Clodan^® 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 Clodan^® 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 Clodan^® 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 Clodan^® Shampoo.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for: Medimetriks Pharmaceuticals, Inc.

383 Route 46 West, Fairfield, NJ 07004-2402

www.medimetriks.com

Manufactured by: Padagis, Yeruham, Israel

Rev. 05/2022

IP035-R3