Tri-Luma® Cream is indicated for the short-term (8 week) treatment of moderate to severe melasma of the face. Tri-Luma® Cream should be used with measures for sun avoidance, like using sunscreen of SPF 30 or higher. Tri-Luma® Cream contains sulfites which may cause severe, life-threatening allergic reactions, so tell your doctor if you are allergic to sulfites. Tri-Luma® Cream 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® Cream. 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 or symptoms of this condition occur. In addition, redness, peeling, burning, dryness and itching may occur. Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided. Tri-Luma® Cream should not be used with irritating products such as abrasive cleansers, scrubs, or skin-peeling agents.

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. For more information about Tri-Luma® Cream, please see full Prescribing Information.

Important Information About the Safety and Side Effects of Tri-Luma® Cream

For more information about the safety and side effects of Tri-Luma® Cream, please refer to the full prescribing information.
What are the possible side effects of Tri-Luma® Cream?

Some patients may have very severe allergic reactions to Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) due to the sulfites contained in the product. In some cases, these allergic reactions may result in severe asthma attacks, which can be life-threatening.

While you use Tri-Luma® Cream, your skin may develop mild to moderate redness, peeling, burning, dryness, or itching.

Tri-Luma® Cream contains a corticosteroid medicine as one of its active components. The following side effects have been reported with application of corticosteroid medicines to the skin: itching, irritation, dryness, infection of the hair follicle, acne, changes in skin color, inflammation around the mouth, allergic skin reaction, skin infection, skin thinning, stretch marks and sweat problems. In addition, Tri-Luma® Cream contains a corticosteroid that may produce reversible effects on the adrenal gland called hypothalamic-pituitary-adrenal (HPA) axis suppression, so tell your doctor if you have any condition that may affect your adrenal function, such as Addison’s disease.

Some patients using Tri-Luma® Cream develop dark spots on their skin, tingling, increased skin sensitivity, rash, acne, skin redness caused by a condition called rosacea, skin bumps, blisters, or tiny red lines or blood vessels showing through the skin. Tri-Luma® Cream may also cause a gradual blue-black darkening of your skin; if this happens, stop using the product immediately and speak to your doctor.

If you are concerned about how your skin is reacting to Tri-Luma® Cream, call
your doctor.

You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION

Tri-Luma® Cream is indicated for the short-term (8 week) treatment of moderate to severe melasma of the face. Tri-Luma® Cream should be used with measures for sun avoidance, like using sunscreen of SPF 30 or higher. Tri-Luma® Cream contains sulfites which may cause severe, life-threatening allergic reactions, so tell your doctor if you are allergic to sulfites. Tri-Luma® Cream 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® Cream. 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 or symptoms of this condition occur. In addition, redness, peeling, burning, dryness and itching may occur. Exposure to sunlight, sunlamps, or UV light and extreme heat, wind, or cold should be avoided. Tri-Luma® Cream should not be used with irritating products such as abrasive cleansers, scrubs, or skin-peeling agents.

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. For more information about Tri-Luma® Cream, please see full Prescribing Information.
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