Download Tri-Luma® Cream

Tri-Luma® Cream
Melasma is a natural darkening of the skin on the face caused by excessive production of
melanin. Melasma can be mild, moderate or severe, depending on how much of the face is
discolored and how much darker than normal the skin has become. Melasma may be triggered
by normal hormonal changes in women — during pregnancy or when taking birth control pills or
hormone replacement therapy.
Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) is the only
treatment of moderate to severe melasma of the face.
Tri- Luma® Cream:
• Proven safe for intermittent use up to six months
within a 12-month period
•
Tri-Luma® Cream is the only hydroquinone (4.0%)based product for melasma approved by the FDA
•
Clinically proven to lighten moderate-to-severe
melasma in eight weeks³ in a high percentage of test
results
•
No skin atrophy and no increase in severity of side
effects versus short-term (8-week) use
•
Fluocinolone acetonide is a low-potency, class 6
steroid
•
Favorable safety profile and well tolerated by
patients³
•
The only melasma therapy that combines three
active ingredients — a low potency corticosteroid
(fluocinolone acetonide), hydroquinone, and
tretinoin — in one stable formulation
•
For best results Tri-Luma® Cream must be used with
measures to avoid sun exposure.
•
Tri-Luma® Cream is for short-term and intermittent
long-term therapy for up to six months of
cumulative drug exposure
For more information on Tri-Luma®, visit www.TriLuma.com.
Tri-Luma® is only available by prescription. For more information on Galderma, visit www.GaldermaUSA.com.
Galderma Laboratories, L.P. • 14501 N. Freeway • Fort Worth, TX 76177
Please see reverse side for more information regarding Tri-Luma®.
Reference:
1. Grimes P. Incidence and psychosocial implications of melasma. Presented at: American Academy of Dermatology; July 25-29, 2003; Chicago, Ill.
3. Taylor SC, et al. Efficacy and Safety of a New Triple-Combination Agent for the Treatment of Facial Melasma. Cutis. 2003; 72: 67-72.
Tri-Luma® Cream is contraindicated in individuals with a hypersensitivity, allergy or intolerance to fluocinolone acetonide, hydroquinone or tretinoin. In clinical trials, the
most frequently reported side effects were erythema, desquamation, burning, dryness and pruritus.
Mild to moderate redness, peeling, burning, dryness or itching may be experienced. This product contains sulfites that may cause severe allergic reactions including
anaphylactic symptoms and life-threatening asthma attacks. Exposure to sunlight, sunlamps or UV light and extreme heat, wind or cold should be avoided. Use of
sunscreen with appropriate SPF of 30 or higher is required. Wear protective clothing and change to nonhormonal forms of birth control, if hormonal methods are used.
Tri-Luma® Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, whose occurrence should prompt
discontinuation of therapy. Tri-Luma® Cream contains the corticosteroid fluocinolone acetonide. Systemic absorption of topical corticosteroids can produce reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment.
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.