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May 23, 2013
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eflornithine topical (cont.)

Who should not use eflornithine topical (Vaniqa)?

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

Eflornithine topical is in the FDA pregnancy category C. This means that it is not known whether eflornithine topical will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant.

It is also not known whether eflornithine passes into breast milk. Do not use eflornithine topical without first talking to your doctor if you are breast-feeding a baby.

Eflornithine topical has not been approved for use by children younger than 12 years of age.

How should I use eflornithine topical (Vaniqa)?

Apply eflornithine topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Eflornithine topical does not permanently remove hair or "cure" unwanted facial hair. It is not a hair remover (depilatory). You will need to continue using your current hair removal techniques. Eflornithine topical will help you manage your condition and improve your appearance.

Eflornithine topical is for external use only.

Eflornithine topical is usually applied twice daily, at least eight hours apart, or as directed by your doctor.

Wash your hands before and after each application of eflornithine topical.

Remove any facial hair that is present using your current hair removal techniques. Wait at least 5 minutes after hair removal before applying eflornithine topical. Apply a thin layer of eflornithine topical to the affected areas of the face and nearby affected areas under the chin and rub it in thoroughly.

Cosmetics or sunscreen may be used after applying eflornithine topical, but you should wait a few minutes to allow the treatment to be absorbed before applying them.

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

Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If eflornithine topical gets in your eyes, rinse them thoroughly with water and contact your doctor.

Eflornithine topical may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of eflornithine topical to once a day. If irritation continues, stop using eflornithine topical and contact your doctor.

Continue to use eflornithine topical 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 with eflornithine topical should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with eflornithine topical.

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

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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