Xolegel

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Ketoconazole topical is an antifungal medication that prevents fungus from growing on your skin.

Ketoconazole topical is used to treat fungal infections of the skin such as athlete's foot, jock itch, ringworm, and seborrhea (dry, flaking skin).

Ketoconazole topical is available as a cream, gel, and as a shampoo. The shampoo is used for the treatment of dandruff.

Ketoconazole topical may also be used for purposes not listed in this medication guide.

You should not use ketoconazole topical if you are allergic to it.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medication.

Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to.

Avoid getting this medication in your eyes, nose, or mouth.

Stop using ketoconazole topical and call your doctor if you have severe burning, irritation, redness, pain, or oozing where the medicine is applied.

Ketoconazole topical gel is flammable. Do not use it while you are smoking or near an open flame.

Do not use this medication on a child younger than 12 years old.

You should not use ketoconazole topical if you are allergic to it.

FDA pregnancy category C. It is not known whether ketoconazole topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ketoconazole topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. You should not breast-feed if you have applied ketoconazole topical to your breast area.

Do not give this medicine to a child younger than 12 years old without medical advice.

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 ketoconazole topical if you are allergic to it.

FDA pregnancy category C. It is not known whether ketoconazole topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ketoconazole topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. You should not breast-feed if you have applied ketoconazole topical to your breast area.

Do not give this medicine to a child younger than 12 years old without medical advice.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use ketoconazole topical to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply a thin layer of the cream or gel to the affected skin area as directed. This medicine is usually used for only 2 to 4 weeks.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying ketoconazole topical.

Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to.

Use the shampoo twice per week, unless your doctor has told you otherwise. Apply enough shampoo to create a lather and massage the scalp for 1 minute. Rinse thoroughly and repeat, leaving the lather on for an additional 3 minutes. Then rinse it off completely. Allow at least 3 days to pass between uses of ketoconazole shampoo.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medication.

Store ketoconazole topical at room temperature away from moisture and heat.

Ketoconazole topical gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ketoconazole topical and call your doctor at once if you have a serious side effect such as:

• severe itching, burning, or irritation where the medicine is applied;

• oily or dry scalp, mild hair loss;

• redness, pain, or oozing of treated skin areas; or

• eye redness, swelling, or irritation.

Less serious side effects include:

• mild skin itching or irritation;

• dry skin; or

• headache.

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.

Xolegel contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle for topical administration.

Chemically, ketoconazole is (±)-cis-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine, with the molecular formula C26H28Cl2N4O4 and a molecular weight of 531.43.

Each gram contains: 20 mg ketoconazole USP, dehydrated alcohol (34%), ascorbic acid, butylated hydroxytoluene, citric acid monohydrate, glycerin, hydroxypropyl cellulose, polyethylene glycol 400, PPG-15 stearyl ether, propylene glycol, FD&C yellow No. 6, and FD&C yellow No. 10.

Xolegel is a smooth, translucent to clear, amber gel.

Study 1 was a multicenter, double-blind, randomized, vehicle-controlled trial which enrolled 459 subjects 12 years of age and older with moderate to severe seborrheic dermatitis. A total of 229 subjects were treated with Xolegel, and 230 subjects were treated with vehicle. All subjects were treated once daily for 14 days, and efficacy was assessed at Day 28 (i.e., 2 weeks after end of treatment). Effective Treatment was defined as:

• an Investigator's Global Assessment score of ≤ 1 (completely clear or almost clear) and
• erythema and scaling scores of 0 (none) if the baseline score was 2, or 1 (mild) if the baseline score was 3.

The proportion of subjects effectively treated is shown in Table 1.

Two additional double-blind, randomized, vehicle-controlled, parallel, and multicenter trials that included a total of 316 subjects treated with Xolegel provided supportive evidence of the efficacy of Xolegel for treatment of seborrheic dermatitis. Subjects applied either Xolegel or vehicle study treatment to the affected area(s) once daily for 14 days and were followed through Day 28. Efficacy was assessed by the proportion of subjects who were completely clear at Day 28.

The contribution to efficacy of individual components of the vehicle has not been established.

[See FDA-Approved Patient Labeling (Patient Information)]

• This medication is to be used as directed by the health care provider. It is for external use only.
• Xolegel may be irritating to mucus membranes. Contact with the eyes, nostrils, and mouth should be avoided.
• As with any topical medication, patients should wash their hands after application.
• This medication should not be used for any disorder other than that for which it has been prescribed.
• Patients should report any signs of adverse reactions to their health care provider.

PATIENT INFORMATION
Xolegel® (Xol-a-gel)
(ketoconazole) Gel, 2%

Read the Patient Information that comes with Xolegel carefully before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your health care provider. If you have any questions about Xolegel, ask your health care provider.

What is Xolegel?

Xolegel is a prescription medicine used on the skin to treat a skin condition called seborrheic dermatitis.

Patients with seborrheic dermatitis can have areas of dry, flaky skin on the scalp, face, ears, chest, or upper back. Xolegel is only to be used in adults and in children older than 12 years of age who have a normal (healthy) immune system. Xolegel has not been studied in children below the age of 12.

It is not known whether Xolegel can be used to treat fungal infections.

Xolegel is a translucent to clear, amber colored gel.

What should I tell my health care provider before using Xolegel?

• Tell your health care provider about all of your medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding or planning to breastfeed. Xolegel should be used during pregnancy and breastfeeding only if needed.
• Tell your health care provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Keep a list of your medicines and show it to your health care provider and pharmacist. Tell your health care provider and pharmacist when you get a new medicine. It is not known if Xolegel and other medicines can interact with each other.

How should I use Xolegel?

• Use Xolegel exactly as prescribed. Talk to your health care provider if your condition gets worse or does not get better by the end of your treatment.
• Wash your hands before and after applying Xolegel.
• Spread a thin layer of Xolegel evenly on the affected skin with your fingertips. Be sure to cover all affected areas.
• Do not wash the areas where you applied Xolegel for at least 3 hours after you apply it.
• Wait at least 20 minutes after you spread Xolegel on your skin before you put makeup or sunscreens on the affected areas.
• Use Xolegel once daily for 2 weeks.

What should I avoid while using Xolegel?

• Xolegel is only to be used on the skin. It is not for eye, mouth, or vaginal use.
• Do not touch your eyes, nose, or mouth while you are applying Xolegel. Wash your hands well after you apply it. Irritation may occur if you get Xolegel in your eyes, nose, or mouth.
• If used during breastfeeding and Xolegel is applied on the chest, take care to avoid accidental ingestion of Xolegel by the baby.
• Xolegel is flammable (it can catch fire). Stay away from heat, flame, or smoking while you are applying Xolegel and right after you apply it.
• This medication should not be used for any disorder other than that for which it has been prescribed.

What are the possible side effects of Xolegel?

• The effects of Xolegel during pregnancy, including whether Xolegel can harm your unborn baby, are not known.
• It is not known if Xolegel can pass into your breastmilk or if it can harm your breastfed baby.
• Stop using Xolegel and talk to your health care provider if you develop itching, a rash, or any skin irritation after using Xolegel.
• Stop using Xolegel and talk to your health care provider if your skin condition (seborrheic dermatitis) gets worse.
• The most common side effect is a burning feeling where Xolegel is applied.
• Report any side effects to your health care provider to receive immediate medical attention. You can also report suspected side effects by calling the US Food and Drug Administration at 1-800-FDA-1088, or reporting via the internet at www.fda.gov/medwatch.

These are not all of the side effects of Xolegel. For more information, ask your health care provider or pharmacist.

How should I store Xolegel?

• Store Xolegel at 59°F to 86°F (15° to 30°C).
• Keep Xolegel and all medicines out of the reach of children.
• Contents are flammable. Avoid storing Xolegel near heat or flame.

General information about Xolegel

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Xolegel for a condition for which it was not prescribed. Do not give Xolegel 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 Xolegel. If you would like more information, talk with your health care provider. You can also ask your pharmacist or health care provider for information about Xolegel that is written for health professionals.

What are the ingredients in Xolegel?

Active ingredient: ketoconazole, USP

Inactive ingredients: dehydrated alcohol, ascorbic acid, butylated hydroxytoluene, citric acid monohydrate, glycerin, hydroxypropyl cellulose, polyethylene glycol 400, PPG-15 stearyl ether, propylene glycol, FD&C yellow No. 6, and FD&C Yellow No. 10.

This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

The Patient Information leaflet was last revised: May 2012

Manufactured by DPT Laboratories, Ltd.,
San Antonio, TX 78215

For Aqua Pharmaceuticals,
An Almirall Company
Exton, PA 19341

Revised 06/2016
Xolegel is a registered trademark of Aqua Pharmaceuticals.

© 2016 Aqua Pharmaceuticals

AQUA PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 45 g Carton

NDC 16110-080-45

Xolegel®
(ketoconazole) Gel, 2%

AQUA
PHARMACEUTICALS

45 grams
Rx only. For topical use only.

PRINCIPAL DISPLAY PANEL - 45 g Carton

NDC 16110-080-45

Xolegel®
(ketoconazole) Gel, 2%

AQUA
PHARMACEUTICALS

45 grams
Rx only. For topical use only.

Use Xolegel exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use Xolegel to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medication.

Spread a thin layer of Xolegel evenly on the affected skin with your fingertips. Be sure to cover all affected areas. The normal dose is to apply Xolegel once daily for 2 weeks.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying Xolegel.

Avoid being near fire, flame, or smoking during and immediately following application of the gel.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the condition is completely cleared.

Store Xolegel at room temperature away from moisture and heat.

Xolegel gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.