Tri-Luma® Cream is indicated for the short-term (8 week) treatment of moderate to severe melasma of the face. Tri-Luma® Cream should be used with measures for sun avoidance, like using sunscreen of SPF 30 or higher. Tri-Luma® Cream contains sulfites which may cause severe, life-threatening allergic reactions, so tell your doctor if you are allergic to sulfites. Tri-Luma® Cream contains hydroquinone, which may cause a gradual blue-black darkening of the skin. If you are pregnant, nursing or trying to become pregnant you should not use Tri-Luma® Cream. Safety and efficacy have not been established in individuals with darker skin. Reversible HPA axis (adrenal function) suppression may result from exposure to the topical corticosteroid, fluocinolone acetonide, so discontinue use if signs or symptoms of this condition occur. In addition, redness, peeling, burning, dryness and itching may occur. Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided. Tri-Luma® Cream should not be used with irritating products such as abrasive cleansers, scrubs, or skin-peeling agents.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For more information about Tri-Luma® Cream, please see full Prescribing Information.

Information About Using Tri-Luma® Cream

What can I expect from treatment with Tri-Luma® Cream?

Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) may improve your melasma, but it is not a cure.

In studies, after 8 weeks of treatment with Tri-Luma® Cream, most patients with moderate to severe melasma had at least some improvement. Some had their dark spots clear up completely (38% in one study and 13% in another). In most patients treated with Tri-Luma® Cream, their melasma came back after treatment.

If the underlying causes of melasma—such as the use of certain birth control pills or too much exposure to sunlight—are not removed, melasma will come back when you stop treatment.

IMPORTANT SAFETY INFORMATION

Tri-Luma® Cream is indicated for the short-term (8 week) treatment of moderate to severe melasma of the face. Tri-Luma® Cream should be used with measures for sun avoidance, like using sunscreen of SPF 30 or higher. Tri-Luma® Cream contains sulfites which may cause severe, life-threatening allergic reactions, so tell your doctor if you are allergic to sulfites. Tri-Luma® Cream contains hydroquinone, which may cause a gradual blue-black darkening of the skin. If you are pregnant, nursing or trying to become pregnant you should not use Tri-Luma® Cream. Safety and efficacy have not been established in individuals with darker skin. Reversible HPA axis (adrenal function) suppression may result from exposure to the topical corticosteroid, fluocinolone acetonide, so discontinue use if signs or symptoms of this condition occur. In addition, redness, peeling, burning, dryness and itching may occur. Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided. Tri-Luma® Cream should not be used with irritating products such as abrasive cleansers, scrubs, or skin-peeling agents.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088. For more information about Tri-Luma® Cream, please see full Prescribing Information.
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