Vaniqa interferes with a chemical in hair follicles under the skin, which slows hair growth where the medicine is applied.

Vaniqa cream is used to reduce unwanted facial hair in women.

Vaniqa cream does not permanently remove facial hair or prevent hair growth.

Vaniqa cream is for external use only.

Continue to use Vaniqa even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Vaniqa cream if you have had an allergic reaction to eflornithine in the past.

It is not known whether Vaniqa cream will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether eflornithine topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Vaniqa is not approved for use by anyone younger than 12 years old.

Apply Vaniqa cream exactly as directed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

Vaniqa cream is usually applied twice daily, at least 8 hours apart. This medicine is for use only on the face and chin. Do not apply to other areas of the body.

Before application, remove any facial hair using your desired hair removal method (razor, tweezers, etc). Wait at least 5 minutes before applying Vaniqa.

Wash your hands before and after applying the medicine.

Apply a thin layer of cream to all affected areas of the face or under the chin and rub in thoroughly.

Wait until the medicine dries completely before you apply cosmetics or sunscreen to treated areas.

Do not wash the treatment areas for at least 4 hours after application of Vaniqa.

If this medicine irritates your skin, you may need to reduce applications to once daily.

Call your doctor if skin irritation does not improve, or if it gets worse.

Vaniqa cream is not a hair remover (depilatory). You will need to continue using your current hair removal techniques. This medicine can help you manage your condition and improve your appearance.

Vaniqa will reduce facial hair growth gradually. Keep using the medicine even if you do not see immediate results. It may take 4 to 8 weeks or longer before you notice improvement.

Stop using this medicine if you do not get the desired results after 6 months of use.

Store at room temperature away from moisture and heat. Do not allow the medicine to freeze.

Hair growth may return to pretreatment levels approximately 8 weeks after you stop using Vaniqa.

Usual Adult Dose for Hirsutism:

Apply a thin layer of Vaniqa cream to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice a day, allowing at least 8 hours between applications or as directed by a physician.

Continue to use hair removal techniques as needed in conjunction with eflornithine. Apply eflornithine at least 5 minutes after hair removal. Cosmetics or sunscreens may be applied over treated areas after cream has dried.

You should not use Vaniqa cream if you have had an allergic reaction to eflornithine in the past.

It is not known whether Vaniqa cream will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether eflornithine topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Vaniqa is not approved for use by anyone younger than 12 years old.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

An overdose of Vaniqa cream is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

If the medicine gets in your eyes, rinse thoroughly with water and contact your doctor.

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

Stop using eflornithine and call your doctor at once if you have:

• severe irritation of treated skin; or

• redness or crusting around your hair follicles.

Common Vaniqa side effects may include:

• temporary redness, rash, burning, stinging, itching, or tingling;

• acne or red bumps on the skin;

• skin dryness; 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.