Important Safety Information
Mild-to-moderate redness, peeling, burning, dryness, or itching may be experienced. People with allergic reactions, such as asthma, to sulfites should not use Tri-Luma
® Cream. The safety and efficacy of Tri-Luma
® Cream in patients with skin types V and VI have not been studied. Excessive bleaching resulting in undesirable cosmetic effects in patients with darker skin cannot be excluded.
The safety and efficacy of Tri-Luma
® Cream in pregnant women and nursing mothers have not been established. 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. Systematic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticoid insufficiency after withdrawal of treatment.
Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided. Use of a broad-spectrum sunscreen with SPF of 30 or higher is required. Wear protective clothing and change to nonhormonal forms of birth control if hormonal methods are used.
For more information about Tri-Luma
® Cream, see
Full Prescribing Information.
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.