Fluocinolone Acetonide, Hydroquinone, Tretinoin Topical cream
What is this medicine?
FLUOCINOLONE; HYDROQUINONE; TRETINOIN (floo oh SIN oh lone; hye droe KWIN ohn; TRET i noe in) is a combination of a corticosteroid, a retinoid similar to vitamin A, and a drug used to lighten the skin. It is used on the skin to treat melasma. Melasma is a condition that causes dark spots on the face, especially the cheeks and forehead.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
an unusual or allergic reaction to fluocinolone or any other corticosteroid, hydroquinone, tretinoin, vitamin A, sulfites, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine 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 medicine should become invisible almost at once. If you can still see the medicine, you are using too much. Use your medicine at regular intervals. Do not use it more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. This medicine 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 medicine?
phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
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 medicine?
Improvement of the treated areas occurs gradually. It may take up to 8 weeks of treatment before the full effects of this medicine 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 medicine to any such affected areas.
If sensitivity or increased irritation occurs or if the melasma spots become darker with treatment, stop using this medicine and contact your doctor.
Do not get this medicine 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 doctor or health care professional.
This medicine 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 medicine if you are pregnant or trying to become pregnant. Ask your doctor or health care professional 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 medicine, unless directed by your doctor or health care professional: 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 doctor or health care professional before using these products.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
crusting or swelling of the treated areas
excessive or persistent burning, irritation, stinging or itching of the treated areas
lightening of the skin surrounding the treated areas (halo hypopigmentation)
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
increased sensitivity to the sun
mild itching or stinging of the treated areas
mild peeling or mildly red, inflamed, and irritated skin
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 medicine?
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.
March 21, 2017
U.S. FDA-approved Package Insert