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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Short-term side effects of oral PUVA may include sunburn, nausea and vomiting, itching, abnormal hair growth, and too much repigmentation or darkening of the treated patches or the normal surrounding skin (hyperpigmentation). If received for longer periods of time, this type of treatment may increase your risk of skin cancer. To avoid sunburn and reduce your risk of skin cancer, you'll need to apply sunscreen and avoid direct sunlight for 24 to 48 hours after each treatment. Wear protective UVA sunglasses for 18 to 24 hours after each treatment to avoid eye damage, particularly cataracts.
Allergic sensitivity to a topical corticosteroid is usually only picked up when an eczematous dermatitis being treated by a topical corticosteroid fails to respond to treatment or worsens. In cases of persistent or exacerbating dermatitis treated with corticosteroid preparations, corticosteroid sensitivity should be considered. However, it may also be due to irritation from or allergy to other components of the preparation such as preservatives . Lanolin , ethylenediamine , quaternium-15 and the antibacterial agent neomycin , are all known to be potent sensitisers.