Ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.

Limitations of Use

Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established.

Ketoconazole foam, 2% should be applied to the affected area(s) twice daily for four weeks.

Hold the container upright, and dispense ketoconazole foam, 2% into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of ketoconazole foam, 2% with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that ketoconazole foam, 2% may be applied directly to the skin (rather than on the hair).

Avoid contact with the eyes and other mucous membranes. Ketoconazole foam, 2% is not for ophthalmic, oral or intravaginal use.

Ketoconazole foam, 2% contains 20 mg of ketoconazole, USP per gram, supplied in 50 g and 100 g containers.

None.

Ketoconazole foam, 2% contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.

The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, cis- with the molecular formula C26H28Cl2N4O4 and a molecular weight of 531.43.

The following is the chemical structure:

Ketoconazole foam, 2% contains 20 mg ketoconazole per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

The safety and efficacy of ketoconazole foam, 2% were evaluated in a randomized, double-blind, vehicle-controlled trial in subjects 12 years and older with mild to severe seborrheic dermatitis. In the trial, 427 subjects received ketoconazole foam, 2% and 420 subjects received vehicle foam. Subjects applied ketoconazole foam, 2% or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. The overall disease severity in terms of erythema, scaling, and induration was assessed at Baseline and week 4 on a 5-point Investigator’s Static Global Assessment (ISGA) scale.

Treatment success was defined as achieving a Week 4 (end of treatment) ISGA score of 0 (clear) or 1 (majority of lesions have individual scores for scaling, erythema, and induration that averages 1 [minimal or faint]) and at least two grades of improvement from baseline. The results are presented in Table 2. The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups.

Table 2: Efficacy Results

Ketoconazole Foam, 2% contains 20 mg of ketoconazole, USP per gram. The thermolabile hydroethanolic foam is available as follows:

• NDC: 72162-1417-1: 100 g aluminum can
• NDC: 72162-1417-2: 50 g aluminum can

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Do not store under refrigerated conditions.

Contents are flammable. Do not expose containers to heat and/or store at temperatures above 49°C (120°F). Do not store in direct sunlight.

Contents under pressure. Do not puncture and/or incinerate container.

Keep out of reach of children.

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

See FDA-approved patient labeling (Patient Package Insert).

Instruct patients on a proper use of ketoconazole foam, 2%.

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Avoid fire, flame and/or smoking during and immediately following application.

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Do not apply ketoconazole foam, 2% directly to hands. Dispense onto a cool surface, and apply to the affected areas using the fingertips.

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Wash their hands after application

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Ketoconazole foam, 2% may cause skin irritation (application site burning and/or reactions)

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Instruct a patient to contact a health care provider if the area of application shows signs of increased irritation and report any signs of adverse reactions.

Manufactured by Padagis®

Yeruham, Israel

www.padagis.com

Rev 02-24

5K200 RC PH6

Product of India

Ketoconazole Foam, 2%

Important Information: Ketoconazole foam, 2% is for use on the skin only. Do not use ketoconazole foam, 2% in your eyes, mouth or vagina.

What is ketoconazole foam, 2%?

Ketoconazole foam, 2% is a prescription medicine used on the skin (topical) to treat seborrheic dermatitis in people 12 years of age and older with a normal immune system.

It is not known if ketoconazole foam, 2% is safe and effective when used to treat fungal infections.

It is not known if ketoconazole foam, 2% is safe and effective in children less than 12 years of age.

Before using ketoconazole foam, 2%, tell your healthcare provider about all of your medical conditions, including if you:

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are pregnant or plan to become pregnant. It is not known if ketoconazole foam, 2% will harm your unborn baby.

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are breastfeeding or plan to breastfeed. It is not known if ketoconazole passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ketoconazole foam, 2%.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ketoconazole foam, 2%?

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Use ketoconazole foam, 2% exactly as your healthcare provider tells you to use it. See the detailed “Instructions for Use” at the end of this leaflet for directions about how to apply ketoconazole foam, 2% the right way.

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Apply ketoconazole foam, 2% to the affected skin area(s) 2 times each day for 4 weeks. You should apply enough ketoconazole foam, 2% to cover the entire affected area(s).

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Talk to your healthcare provider if your skin does not improve after 4 weeks of treatment with ketoconazole foam, 2%.

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Dispense ketoconazole foam, 2% directly into the cap. Do not dispense ketoconazole foam, 2% directly onto your hands, because the foam will begin to melt on contact with warm skin.

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Wash your hands after applying ketoconazole foam, 2%.

What should I avoid while using ketoconazole foam, 2%?

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Ketoconazole foam, 2% is flammable. Avoid fire, flames, or smoking during and right after you apply ketoconazole foam, 2% to your skin.

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Avoid getting ketoconazole foam, 2% in or near your eyes, mouth, lips or vagina. If you get ketoconazole foam, 2% on your lips or in your eyes, mouth or vagina, rinse well with water.

What are the possible side effects of ketoconazole foam, 2%?

Ketoconazole foam, 2% may cause serious side effects, including:

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Skin irritation at the application area(s), including skin reactions caused by exposure to light. Tell your healthcare provider if you develop skin irritation during treatment with ketoconazole foam, 2%.

The most common side effects of ketoconazole foam, 2% include, burning, dryness, redness, irritation, numbness, itching, rash and warmth at the application site.

These are not all of the possible side effects of ketoconazole foam, 2%.

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

How should I store ketoconazole foam, 2%?

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Store ketoconazole foam, 2% at room temperature between 68°F to 77°F (20°C to 25°C).

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Do not store the ketoconazole foam, 2% can in the refrigerator or freezer.

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Keep ketoconazole foam, 2% away from heat. Never throw the ketoconazole foam, 2% can into a fire, even if the can is empty.

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Do not store ketoconazole foam, 2% at temperatures above 120°F (49°C).

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Do not break through (puncture) the ketoconazole foam, 2% can.

Keep ketoconazole foam, 2% and all medicines out of the reach of children.

General information about the safe and effective use of ketoconazole foam, 2%.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ketoconazole foam, 2% for a condition for which it was not prescribed. Do not give ketoconazole foam, 2% to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ketoconazole foam, 2% that is written for health professionals.

What are the ingredients in ketoconazole foam, 2%?

Active ingredient: ketoconazole

Inactive Ingredients: cetyl alcohol, citric acid, ethanol 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant

For more information, call Padagis at 1-866-634-9120

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

Ketoconazole Foam, 2%

Important Information: Ketoconazole foam, 2% is for use on the skin only. Do not use ketoconazole foam, 2% in your eyes, mouth or vagina.

Step 1: Remove the clear cap from the ketoconazole foam, 2% can.

Step 2: Hold the can upright and firmly press the nozzle to dispense ketoconazole foam, 2% into the clear cap.

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Dispense enough ketoconazole foam, 2% to cover the entire affected area(s).

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If the can seems warm or the foam seems runny, run the can under cold water.

Step 3: Pick up small amounts of ketoconazole foam, 2% with your fingertips and gently rub the foam into the affected area(s) until the foam disappears.

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If you are treating areas such as your scalp, part the hair so that ketoconazole foam, 2% may be applied directly to the skin.

Step 4: Wash your hands after applying ketoconazole foam, 2%.

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Throw away any of the unused medicine that is left in the cap.

How should I store ketoconazole foam, 2%?

•

Store ketoconazole foam, 2% at room temperature between 68°F to 77°F (20°C to 25°C).

•

Do not store the ketoconazole foam, 2% can in the refrigerator or freezer.

•

Keep ketoconazole foam, 2% away from heat. Never throw the can into a fire, even if the can is empty.

•

Do not store ketoconazole foam, 2% at temperatures above 120°F (49°C).

•

Do not break through (puncture) the ketoconazole foam, 2% can.

Keep ketoconazole foam, 2% and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Rx Only

Manufactured by Padagis®

Yeruham, Israel

www.padagis.com

Rev 02-24

5K200 RC PH6

Product of India

Ketoconazole 2% Foam