Eflornithine Hydrochloride Topical cream [Cosmetic Use]

What is this medicine?

EFLORNITHINE (ee FLOR ni theen) is used on the skin to reduce unwanted facial hair in women.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an unusual or allergic reaction to eflornithine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for external use only. Do not take by mouth. Follow the direction on the prescription label. Wash your hands before and after use. Apply a thin film of cream to the affected areas of the face and chin twice a day (at least 8 hours apart), or as often as directed by your doctor or health care professional. Rub the cream in thoroughly. Do not wash the treatment area for at least 4 hours after application of the cream. Wait a few minutes after applying this cream before you apply cosmetics or sunscreens. This cream does not permanently remove unwanted facial hair. Continue to use your normal method for hair removal until desired results have been achieved. Do not use your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for girls as young as 12 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other skin products on the affected area without asking your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Improvement of the condition occurs gradually. It may take 4 to 8 weeks. If there is no improvement after 6 months, talk to your doctor about stopping this medicine. About 8 weeks after stopping treatment with this medicine, the hair will return to the same condition as before treatment.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• hair bumps

• redness

• stinging or burning

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.