Vaniqa Cream is used for:

Slowing the growth of unwanted facial hair in women.

Vaniqa Cream is an enzyme inhibitor. It works by blocking an enzyme necessary for hair to grow.

Do NOT use Vaniqa Cream if:

• you are allergic to any ingredient in Vaniqa Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vaniqa Cream:

Some medical conditions may interact with Vaniqa Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have scraped or broken skin, or sores on the affected area

Some MEDICINES MAY INTERACT with Vaniqa Cream. However, no specific interactions with Vaniqa Cream are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vaniqa Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vaniqa Cream:

Use Vaniqa Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Vaniqa Cream comes with an additional patient leaflet. Read it carefully and reread it each time you get this medicine refilled. Ask your doctor or pharmacist any questions that you may have about Vaniqa Cream.
• Apply a thin layer of Vaniqa Cream to the affected areas of the face and under the chin, at least 5 minutes after hair removal (eg, plucking, shaving). Rub in thoroughly. Do not wash the treated area for at least 4 hours. Wait at least 8 hours between applications of Vaniqa Cream.
• Cosmetics or sunscreens may be applied to treated areas after Vaniqa Cream has dried.
• If you miss a dose of Vaniqa Cream, skip the missed dose and return to your regular dosing schedule. Do not apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Vaniqa Cream.

Important safety information:

• Vaniqa Cream is for external use only. Avoid contact with the vaginal area, eyes, nose, or mouth.
• Vaniqa Cream does not remove hair. You will need to continue your routine method of hair removal while using Vaniqa Cream.
• You may need to use Vaniqa Cream for at least 4 to 8 weeks before you begin to see improvement. If your symptoms do not improve or become worse, contact your doctor.
• Use Vaniqa Cream with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Vaniqa Cream during pregnancy. It is unknown if Vaniqa Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Vaniqa Cream, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Vaniqa Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Redness; skin tingling; temporary stinging or burning.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding or irritation of the skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Vaniqa Cream may be harmful if swallowed. Symptoms may include dizziness; facial swelling; hair loss; headache; hearing loss; loss of appetite; seizures; unusual bruising or bleeding; upset stomach; weakness.

Proper storage of Vaniqa Cream:

Store Vaniqa Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vaniqa Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Vaniqa Cream, please talk with your doctor, pharmacist, or other health care provider.
• Vaniqa Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Vaniqa Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.