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FLUOCINOLONE/TRETINOIN/HYDROQUINONE - TOPICAL

IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

FLUOCINOLONE/TRETINOIN/HYDROQUINONE - TOPICAL

(flew-oh-SIN-oh-lone/tret-ih-NO-in/hi-dro-KWIN-own)

COMMON BRAND NAME(S): Tri-Luma

USES: This combination medication is used to treat melasma on the face. Melasma is a condition of dark-colored, patchy areas on the skin. This medication may improve your melasma but it is not a cure. Continued exposure to some of the causes of melasma (e.g., sunlight, estrogen-type birth control hormones) may cause it to return.

HOW TO USE: Before using, gently wash your face and neck with a mild soap/cleanser. Rinse and pat dry the skin. Apply a thin layer of medication to the affected area, including about one-half inch of normal appearing skin around the affected area, once daily 30 minutes before bedtime; or use as directed by your doctor. Rub the medication into the skin gently and completely. It may take up to 4 weeks to notice significant improvement. However, this medication is not recommended for long-term use (e.g., greater than 8 weeks). If you experience dry skin from using this medication, you may use a skin moisturizer to help treat this effect; it is recommended to use the moisturizer in the morning after washing your face. Avoid getting any of this medication in your mouth, nose, eyes, or broken areas of skin (e.g., sores). Severe irritation requiring medical attention may occur.

SIDE EFFECTS: Skin irritations (e.g., redness, dryness, itching, or mild burning) may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: a gradual blue-black darkening of the skin (ochronosis), skin blistering or swelling. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: vision problems, headache, increased thirst or urination, unusual weakness, weight loss, nausea, dizziness. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice any other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: open or broken areas of skin (especially on the face or hands), any allergies (especially to sulfites, certain generics of this medication contain sulfites). Though very unlikely, it is possible this medication may be absorbed into your bloodstream. This may have undesirable consequences that may require additional corticosteroid treatment. This is especially true for children and for those who have used this for an extended period if they also have serious medical problems such as serious infections, injuries or surgeries. This precaution applies for up to one year after stopping use of this drug. Consult your doctor or pharmacist for more details. Your skin condition and this medication may make you more sensitive to the effects of the sun. It is recommended that you avoid prolonged sun exposure, use a sunscreen, and wear protective clothing when outdoors. Avoid the use of sunlamps. Consult your doctor or pharmacist for more details. Excessive bleaching of the skin, resulting in an undesirable cosmetic effect in those with darker skin, might occur in some cases. Consult your doctor or pharmacist for more details. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Based on information of related drugs, medication(s) in this product may pass into breast milk. Therefore, consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially: other medicated skin products (e.g., soaps, cleansers, skin medications, skin-drying cosmetics), hormone-based birth control products (e.g., birth control pills, hormone implants). Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. This medicine may be harmful if swallowed. For example tretinoin, when taken by mouth, has caused fetal harm during pregnancy.

NOTES: Do not share this medication with others. Inform all your doctors you use {or have used} this medication.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze.