Fluocinolone is a steroid that reduces inflammation or swelling.

Hydroquinone is a skin bleaching agent.

Tretinoin is a form of vitamin A that helps the skin to renew itself more quickly.

Tri-Luma (for use on the skin) is a combination medicine used to treat melasma (dark skin patches) on the face.

Tri-Luma may also be used for purposes not listed in this medication guide.

Avoid exposure to sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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. Tri-Luma is for use only on the skin. If this medicine gets in your eyes or mouth, rinse with water.

Tri-Luma is usually applied once per day, at least 30 minutes before bedtime. Follow your doctor's instructions.

Gently wash your face with a mild cleanser before applying this medicine. Rinse and pat dry the skin.

Apply a thin film of the medicine only to skin affected by melasma, as well as about 1/2 inch of the surrounding skin. Avoid getting the medicine on your lips or in the creases of your nose.

Do not cover treated skin with a bandage. Bandaging can increase the amount of drug absorbed through your skin and may cause harmful effects.

Wash your hands after applying the medicine.

Tri-Luma is for short-term use only until you get the desired results. This medicine should not be used on a regular basis to prevent further skin discoloration.

Using use this medicine in larger amounts or applying it more often than prescribed will not make it work any faster, and it may increase side effects.

Tri-Luma should be used as part of a complete skin care program that includes avoiding sunlight, using an effective sunscreen (minimum SPF of 30), and wearing protective clothing.

Store at room temperature away from moisture and heat.

Do not share this medicine with another person, even if they have the same symptoms you have.

You should not use Tri-Luma if you are allergic to fluocinolone, hydroquinone, or tretinoin.

To make sure this medicine is safe for you, tell your doctor if you have:

• asthma; or

• a sulfite allergy.

Using Tri-Luma during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.

The pill form of tretinoin is known to cause birth defects. Although your skin does not absorb as much tretinoin as if you were taking the medicine by mouth, it may be best not to use Tri-Luma if you are pregnant. Talk to your doctor first.

Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) can cause melasma to get worse. Ask your doctor about using a non hormonal birth control (condom, diaphragm with spermicide) instead.

It is not known whether fluocinolone, hydroquinone, and tretinoin topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember, or wait until the next night to apply the medicine. Do not use extra medicine to make up the missed dose.

An overdose of Tri-Luma applied to the skin 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 exposure to sunlight or tanning beds. Tri-Luma can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Your skin may be more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing cream or lotion as needed.

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. Do not use other medicated skin products unless your doctor has told you to.

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

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

• darkening or discoloration of treated skin;

• irritation of your eyes, nose, or mouth;

• severe skin redness, itching, peeling, blistering, or crusting;

• severe burning or swelling of the skin; or

• possible signs of absorbing fluocinolone through your skin--worsening tiredness or muscle weakness; loss of appetite, diarrhea; weight loss or weight gain (especially in your face or your upper back and torso); slow wound healing, thinning skin, increased body hair; changes in sexual function; depression, anxiety, feeling irritable.

Common side effects of Tri-Luma may include:

• acne; or

• mild redness, burning, itching, dryness, or peeling of your skin.

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.

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluocinolone, hydroquinone, and tretinoin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.