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.
Who should not use Tri-Luma® Cream?

You should not use Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) if you are allergic to sulfites, as you may have a life-threatening allergic reaction. You should also not use Tri-Luma® Cream if you are allergic to any of its ingredients. Please refer to the full prescribing information for a complete list of ingredients.

You should also be aware that the use of Tri-Luma® Cream in pregnant women may carry the chance of causing birth defects in the baby. Tell your doctor if you are pregnant, may be pregnant, or plan to become pregnant.

Your doctor will talk with you about the benefits and risks of using Tri-Luma® Cream during pregnancy to help decide if the benefits for you are greater than the risks. You may decide to delay treatment until after your baby is born. Using Tri-Luma® Cream early in pregnancy may be more likely to produce birth defects than using it later in pregnancy.

The safety and efficacy of Tri-Luma® Cream in people with darker skin (Fitzpatrick skin types V and VI) has not been studied. 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.

Only your doctor can determine if Tri-Luma® Cream is a good treatment option for you.

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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