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

Eflornithine topical is used to reduce unwanted facial hair in women.

Eflornithine topical does not permanently remove facial hair or prevent hair growth.

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

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.

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.

Eflornithine topical 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 eflornithine topical.

Wash your hands before and after applying the medicine.

Apply a thin layer 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 eflornithine topical.

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.

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

Eflornithine topical 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 eflornithine topical.

Usual Adult Dose for Hirsutism:

Apply a thin layer to the affected area(s) of the face and under the chin twice a day allowing at least 8 hours between applications

Comments:
-This drug has only been studied on the face and adjacent involved areas under the chin and therefore usage should be limited to these areas of involvement.
-The treated area should not be washed for at least 4 hours.
-The patient should continue to use hair removal techniques in conjunction with this drug with application of this cream at least 5 minutes after hair removal.

Use: For the reduction of unwanted facial hair in women

Usual Pediatric Dose for Hirsutism:

12 years or older: Apply a thin layer to the affected area(s) of the face and under the chin twice a day allowing at least 8 hours between applications

Comments:
-This drug has only been studied on the face and adjacent involved areas under the chin and therefore usage should be limited to these areas of involvement.
-The treated area should not be washed for at least 4 hours.
-The patient should continue to use hair removal techniques in conjunction with this drug with application of this cream at least 5 minutes after hair removal.

Use: For the reduction of unwanted facial hair in women

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

It is not known whether eflornithine topical 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.

Eflornithine topical 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 eflornithine topical 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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Eflornithine may cause serious side effects. 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 side effects of eflornithine topical 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.