IMPORTANT SAFETY INFORMATION
Indication : TRI‐LUMA ® 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 contains sulfites which may cause severe, life‐threatening allergic reactions in people allergic to sulfites. TRI‐LUMA 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. 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.
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In an embryofetal development study in pregnant rabbits, beclomethasone dipropionate administration during organogenesis from gestation days 7 to 16 at subcutaneous doses equal to and greater than times the MRHDID in adults (on a mg/m 2 basis at maternal doses of mg/kg/day and higher) produced external and skeletal malformations and embryolethal effects (increased fetal resorptions). There were no effects in fetuses of pregnant rabbits administered a subcutaneous dose times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of mg/kg/day).
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