Fluocinolone Acetonide (floo-oh-SIN-oh-lone a-SEET-oh-nide), Hydroquinone (hye-droe-KWIN-one), Tretinoin (TRET-i-noin)

Treats melasma (skin discoloration) of the face.

Brand Name(s):

Tri-Luma

When This Medicine Should Not Be Used:

How to Use This Medicine:

Cream

• Your doctor will tell you how much medicine to use. Do not use more than directed. Apply the medicine at least 30 minutes before bedtime.
• Use this medicine only on your skin. Rinse it off right away if it gets on a cut or scrape. Do not get the medicine in your eyes, nose, or mouth.
• Wash your hands with soap and water before and after you use this medicine.
• Wash your face and neck with warm water and a mild cleanser. Rinse well and pat dry.
• Apply a thin layer of the medicine to the affected area. Rub it in gently.
• Do not cover the treated area with a bandage unless directed by your doctor.
• This medicine is not for long-term use.

If a dose is missed:

• Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in the refrigerator. Do not freeze.
• Ask your pharmacist or doctor how to dispose of the medicine container and any leftover or expired medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor right away if you become pregnant while you are using this medicine. Tell your doctor if you have Cushing syndrome or diabetes. Tell your doctor if you are allergic to sulfites.
• This medicine may cause a condition called exogenous ochronosis, a blue-black discoloration of the skin. Check with your doctor right away if you have a gradual darkening of the skin.
• This medicine may make your skin more sensitive to sunlight, wind, and cold weather. Avoid sunlamps and tanning beds. Use a sunscreen with a sun protection factor of SPF 30 or higher during the day. Wear protective clothing, such as a hat, when you are outdoors.
• Dry or red skin, peeling, burning, or itching can occur. Avoid cleansers or cosmetics that may dry or irritate your skin. Use a moisturizer as needed.
• If you have a sunburn, stop using this medicine until your skin is healed.
• Do not use this medicine to treat a skin problem your doctor has not examined.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blue-black darkening of the skin
• Color changes on the skin, dark freckles, easy bruising, muscle weakness
• Irritation around your eyes, nose, or mouth
• Round, puffy face
• Severe or ongoing skin redness, burning, peeling, blistering, crusting, or swelling

If you notice these less serious side effects, talk with your doctor:

• Acne or raised spots on the skin
• Mild skin dryness, itching, peeling, burning, or redness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088