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.
How long will treatment with Tri-Luma® Cream take to lighten my melasma?

Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) is indicated for the short-term (up to 8 weeks) treatment of moderate to severe melasma of the face. It is not for long-term use (more than 8 weeks) or for the maintenance of melasma symptoms.

In studies, after 8 weeks of treatment with Tri-Luma® Cream, most patients had at least some improvement. Some had their dark spots clear up completely (38% in one study and 13% in another), but most subjects had their melasma recur after treatment was discontinued.

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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