Alera (for the skin) is used to lighten areas of darkened skin such as freckles, age spots, melasma (sun damage), or chloasma (darkened skin caused by hormonal changes).

Alera 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.

Use exactly as directed on the label, or as prescribed by your doctor.

Alera is usually applied each morning and at bedtime. Follow your doctor's dosing instructions very carefully.

Do not take by mouth. Topical medicine is for use only on the skin.

Before you start using Alera, use a "test dose" to see if you have an allergic reaction to this medicine. Apply a very small amount of the medicine to a small area of healthy skin, and check the area within 24 hours. If there is no reaction other than minor redness, begin using the full prescribed amount of the medicine.

Wash your hands before and after applying this medicine, unless you are using it to treat the skin on your hands.

Apply this medicine only to the affected skin areas that need to be lightened. Try not to get any medicine on the skin around these areas.

Do not use Alera on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

Call your doctor if your symptoms do not improve after 2 months, or if your condition gets worse.

Store at room temperature away from moisture and heat. Keep the container tightly closed when not in use.

You should not use Alera if you are allergic to hydroquinone or peroxide.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• liver or kidney disease;

• asthma or sulfite allergy; or

• if you are using any antibiotic medicine.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Do not give this medicine to anyone under 12 years old without medical advice.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

An overdose of Alera 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.

Avoid getting Alera in your eyes.

Avoid getting this medicine on your lips or inside your nose or mouth. Hydroquinone may cause numbness in these areas.

Avoid exposure to sunlight or tanning beds. Alera can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Some hydroquinone products may contain sunscreen. Check the medicine label or ask your doctor to be sure.

Alera may make your skin more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing lotion as needed.

Using Alera together with benzoyl peroxide, hydrogen peroxide, or other peroxide products may stain your skin. This staining can usually be removed with soap and water.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

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

Alera may cause serious side effects. Stop using Alera and call your doctor at once if you have:

• severe skin redness, burning, or stinging;

• severe skin dryness, cracking, or bleeding;

• blisters or oozing; or

• blue or black discoloration of the skin (especially if you are Hispanic or African-American).

Common side effects of Alera may include:

• mild burning or stinging of treated skin; or

• mild itching, redness, or other irritation.

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.