Please consult full prescribing information for CLODERM® Cream. Not valid for patients reimbursed by federal health care programs, including Medicare, Medicaid, Tricare, the Department of Veterans Affairs, state maternal and child health block grant programs under 42 . 701 et. seq. state social service block grant programs under 42 . section 1397 et. seq. or any other similar federal or state health care program. Void where prohibited by law, taxed or restricted. Void outside the United States. Void for residents of Massachusetts except for cash-paying patients. The CLODERM® Cream brand offer is void in California, however the generic equivalent offer is valid. Patient is responsible for reporting receipt of card program rewards to any private insurer that pays for or reimburses any part of the prescriptions filled with this card. Void if reproduced. It is illegal for any person to sell, purchase, or trade, or offer to sell, purchase or trade, or to counterfeit this card. Offer expires 12 months after initial use . Promius Pharma reserves the right to rescind, revoke or amend this offer at any time without notice.
In controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of Mometasone Furoate Cream % was %. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of Mometasone Furoate Cream % have also been received. In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of Mometasone Furoate Cream % was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis.
The following adverse reactions were reported to be possibly or probably related to treatment with Mometasone Furoate Cream % during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 subjects treated with Mometasone Furoate Cream % in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1.
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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