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Fluocinolone/Hydroquinone/Tretinoin is used for:

Short-term treatment of moderate to severe melasma (darkening) of the face. It is used in combination with sun avoidance measures, including sunscreen use. It may also be used for other conditions as determined by your doctor.

Fluocinolone/Hydroquinone/Tretinoin is a combination topical corticosteroid, depigmentation agent, and keratolytic. Exactly how Fluocinolone/Hydroquinone/Tretinoin works to treat melasma is unknown.

Do NOT use Fluocinolone/Hydroquinone/Tretinoin if:

• you are allergic to any ingredient in Fluocinolone/Hydroquinone/Tretinoin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluocinolone/Hydroquinone/Tretinoin :

Some medical conditions may interact with Fluocinolone/Hydroquinone/Tretinoin . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have eczema, an abnormally high white blood cell count, a sunburn, or asthma
• if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin
• if you have measles, tuberculosis (TB), chickenpox, or shingles, or you have had a positive TB test or a recent vaccination

Some MEDICINES MAY INTERACT with Fluocinolone/Hydroquinone/Tretinoin . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Corticosteroids (eg, prednisone) because the risk of their side effects may be increased by Fluocinolone/Hydroquinone/Tretinoin
• Medicines that may increase your risk of sunburn (eg, tetracycline, hydrochlorothiazide). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase your sunburn risk.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluocinolone/Hydroquinone/Tretinoin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluocinolone/Hydroquinone/Tretinoin :

Use Fluocinolone/Hydroquinone/Tretinoin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Fluocinolone/Hydroquinone/Tretinoin . Talk to your pharmacist if you have questions about this information.
• Fluocinolone/Hydroquinone/Tretinoin is for external use only.
• Apply Fluocinolone/Hydroquinone/Tretinoin at least 30 minutes before bedtime.
• Wash your hands before and after using Fluocinolone/Hydroquinone/Tretinoin .
• Gently wash your face and neck with a mild cleanser. Use your fingers, not a washcloth, to apply the cleanser. Rinse and pat the skin dry. Apply a thin film of medicine to the areas of melasma including about ½ inch of normal appearing skin surrounding each lesion. Rub lightly until the medicine is evenly distributed.
• Do not cover or bandage the treated area unless otherwise directed by your doctor.
• You may apply a moisturizer to the face in the morning after washing.
• If you miss a dose of Fluocinolone/Hydroquinone/Tretinoin , skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluocinolone/Hydroquinone/Tretinoin .

Important safety information:

• Avoid getting Fluocinolone/Hydroquinone/Tretinoin in your eyes, nose, or mouth. If you get Fluocinolone/Hydroquinone/Tretinoin in your eyes, rinse thoroughly with water.
• Do not use Fluocinolone/Hydroquinone/Tretinoin on open wounds.
• Fluocinolone/Hydroquinone/Tretinoin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Fluocinolone/Hydroquinone/Tretinoin . Use a sunscreen (minimum SPF 30) or wear protective clothing if you must be outside for more than a short time.
• Talk with your doctor before you use any other medicines or products on your skin. Avoid using other topical medication, medicated or abrasive soaps, or other products that have a strong drying effect or a high alcohol content. While you are using Fluocinolone/Hydroquinone/Tretinoin , you may use cosmetics and/or moisturizers.
• Do not apply Fluocinolone/Hydroquinone/Tretinoin to skin that is sunburned. Wait until the burn is fully healed before using Fluocinolone/Hydroquinone/Tretinoin .
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Talk with your doctor before you receive any vaccine while you are taking Fluocinolone/Hydroquinone/Tretinoin .
• Hormonal contraceptives (eg, birth control pills) may cause or worsen melasma. If you are using hormonal contraception, talk with your doctor about the use of an alternative form of birth control.
• Do not use Fluocinolone/Hydroquinone/Tretinoin for any condition other than that for which it was prescribed.
• Weather extremes, such as windy or cold weather, may irritate your skin more while you are using Fluocinolone/Hydroquinone/Tretinoin .
• Fluocinolone/Hydroquinone/Tretinoin may cause a gradual blue-black darkening of the skin. Black patients may be at higher risk for this side effect. Contact your doctor immediately if you develop this symptom.
• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
• Fluocinolone/Hydroquinone/Tretinoin may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• Fluocinolone/Hydroquinone/Tretinoin should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Fluocinolone/Hydroquinone/Tretinoin .
• PREGNANCY and BREAST-FEEDING: It is not known if Fluocinolone/Hydroquinone/Tretinoin may cause harm to the fetus after topical use. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluocinolone/Hydroquinone/Tretinoin while you are pregnant. It is not known if Fluocinolone/Hydroquinone/Tretinoin is found in breast milk after topical use. If you are or will be breast-feeding while you use Fluocinolone/Hydroquinone/Tretinoin , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluocinolone/Hydroquinone/Tretinoin :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; numbness or tingling of the skin; redness, peeling, mild burning, irritation, stinging, dryness, itching, or feeling of warmth at the application site; sensitivity to sunlight.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive hair growth; gradual blue-black darkening of the skin; inflamed hair follicles; inflammation around the mouth; loss of skin color; muscle weakness; severe or persistent burning, redness, swelling, blistering, oozing, crusting, or irritation of the skin; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include clumsiness; dizziness; excessive redness, peeling, and discomfort; flushing; headache; stomach pain. Fluocinolone/Hydroquinone/Tretinoin may be harmful if swallowed.

Store Fluocinolone/Hydroquinone/Tretinoin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly closed container. Store away from heat and light. Do not store in the bathroom. Keep Fluocinolone/Hydroquinone/Tretinoin out of the reach of children and away from pets.

General information:

• If you have any questions about Fluocinolone/Hydroquinone/Tretinoin , please talk with your doctor, pharmacist, or other health care provider.
• This medicine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fluocinolone/Hydroquinone/Tretinoin . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.