Fluocinolone; Hydroquinone; Tretinoin Cream

What is this medication?

FLUOCINOLONE; HYDROQUINONE; TRETINOIN (floo oh SIN oh lone; hye droe KWIN ohn; TRET i noe in) treats dark spots on the skin caused by hormones. It works by decreasing the amount of melanin, a pigment your body makes that gives your skin color. This reduces the appearance of dark spots. Sun prevention measures, including sunscreen, are often combined with this medication. It is a combination of a topical steroid, a skin-lightening agent, and a retinoid.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tri-Luma

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Sunburn
• An unusual or allergic reaction to fluocinolone or any other corticosteroid, hydroquinone, tretinoin, vitamin A, sulfites, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for external use only. Follow the directions on the prescription label. Gently wash your face with a mild cleanser. Do not use a washcloth to cleanse, just use your fingers. Rinse and pat your skin dry. Apply just enough cream to cover the discolored spots and about one-half inch of the normal skin surrounding the affected area. Lightly rub onto your skin. The medication should become invisible almost at once. If you can still see the medication, you are using too much. Use your medication at regular intervals. Do not use it more often than directed.

Talk to your care team about the use of this medication in children. This medication is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip that dose and continue with your regular schedule. Do not use double or extra doses.

What may interact with this medication?

• Aminolevulinic acid
• Benzoyl peroxide
• Certain antibiotics
• Phenothiazines, such as chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Porfimer
• Thiazide diuretics, such as hydrochlorothiazide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Improvement of the treated areas occurs gradually. It may take up to 8 weeks of treatment before the full effects of this medication are seen. After stopping treatment, the melasma spots may darken again over time and return.

Excessive or prolonged application of this cream may cause the treated areas or surrounding skin to become temporarily lighter than your normal skin. Discontinue application of this medication to any such affected areas.

If sensitivity or increased irritation occurs or if the melasma spots become darker with treatment, stop using this medication and contact your care team.

Do not get this medication in the eyes, inside the nose, on wounds, or any other sensitive areas of skin. If it gets in your eyes, rinse thoroughly with water and contact your care team.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Do not use this medication if you are pregnant or trying to become pregnant. Ask your care team for effective birth control measures if you are a female and able to have children.

To reduce skin dryness you may use a moisturizer in the morning after you wash your face.

Do not use the following products on the same areas that you are treating with this medication, unless directed by your care team: other topical agents with a strong skin drying effect such as products with a high alcohol content, astringents, spices, the peel of lime or other citrus, medicated soaps or shampoos, permanent wave solutions, electrolysis, hair removers or waxes, or any other preparations or processes that might dry or irritate your skin. Ask your care team before using these products.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Burning, itching, crusting, or peeling of treated skin
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Acne
• Change in skin color
• Dry mouth
• Mild skin irritation, redness, or dryness
• Sensitivity to light

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.