Kuric

: Yes

Tablets: 200 mg; Shampoo: 1% and 2%; Cream: 2%, Gel: 2%, Foam: 2%

• Store tablets at room temperature, 15 C to 25 C (59 F to 77 F) and protected from moisture.
• Store shampoo 1% between 2 C to 30 C (35 F to 86 F) and protected from light and freezing.
• Store shampoo 2% at or below 25 C (77 F) and protected from light.
• Store cream and foam at room temperature, 20 C to 25 C (68 F to 77 F).
• Store gel between 15C to 30 C (59 F to 86 F).

Kuric™ (ketoconazole) 2% cream, for topical administration only, contains the broad-spectrum synthetic antifungal agent, ketoconazole 2% cream, formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula:

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

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.

There may be other drugs that can affect ketoconazole topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

• It is used to treat fungal infections of the skin.

• Tell all of your health care providers that you take Kuric. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you use other drugs or products on your skin.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.
• Irritation where this medicine is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to ketoconazole topical: topical cream, topical foam, topical gel/jelly, topical shampoo, topical solution

Along with its needed effects, ketoconazole topical (the active ingredient contained in Kuric) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ketoconazole topical:

• Itching, stinging, burning, or irritation not present before use of this medicine

• Acne
• bleeding from sore in the mouth
• blistering, crusting, irritation, itching, or reddening of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• cracked, dry, or scaly skin
• discoloration of the fingernails or toenails
• dizziness
• eye dryness, irritation, or swelling
• red rash with watery, yellow-colored, or pus filled blisters with or without thick yellow to honey-colored crusts
• skin dryness, pain, rash, redness, or swelling
• sore in the mouth or on the gums
• swelling of the face

• Hair loss and irritation

• Pain

• Blistering, burning, crusting, dryness, or flaking of the skin
• burning sensation of the skin
• burning, itching, redness, skin rash, swelling, or soreness at the application site
• discoloration of the hair
• dry skin
• fast heartbeat
• fever
• hives
• hoarseness
• irritation
• itching, scaling, severe redness, or soreness of the skin
• joint pain, stiffness, or swelling
• rash
• shortness of breath
• swelling of the eyelids, face, lips, hands, or feet
• thinning of the hair
• tightness in the chest
• troubled breathing or swallowing
• wheezing

Some side effects of ketoconazole topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dryness or oiliness of the hair and scalp
• headache

• Abnormal hair texture
• mild dryness of the skin
• scalp pustules