IMPORTANT SAFETY INFORMATION
Indication: TRI‐LUMA® (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) Cream is indicated for the short‐term (up to 8 weeks) treatment of moderate to severe melasma of the face in the presence of measures for sun avoidance, including the use of sunscreens. Adverse Events: In the controlled clinical trials, the most frequently reported events were redness, peeling, burning, dryness, and itching at the site of application. Warnings/Precautions: TRI‐LUMA® Cream contains sulfites which may cause severe, life‐threatening allergic reactions in people 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 and symptoms of this condition occur. Avoid products that may dry or irritate the skin, such as abrasive cleansers, scrubs, or skin‐peeling agents. Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided. If exposure cannot be avoided, sunscreen products [SPF 30 or more] and protective apparel should be used.
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.
*The Galderma® CAREConnect™ Program (“Program”) is brought to you by Galderma Laboratories, L.P. (“Galderma”). The Program is only available for commercially unrestricted or commercially restricted/cash paying patients. Patients who are enrolled in state or federally government-run or government-sponsored healthcare plan with a pharmacy benefit are not eligible to use the Galderma CAREConnect Patient Savings Card (“Card”). Any claim under the Program must be submitted by participating pharmacies to one of the Administrators of the Program.