Tri-luma® (fluocinolone acetonide, tretinoin, hydroquinone) Pregnancy C

How Supplied:

Fluocinolone acetonide 0.1%, tretinoin 0.05%, and hydroquinone 4% cream, 30 g

Indications and Usage:

Tri-Luma Cream is indicated for the short-term (8 week) intermittent treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.

Prescribing Instructions:

Prescribing Information Instructions [PDF]

Side Effects and Contraindications:

Tri-Luma Cream should be used with measures for sun avoidance, like using sunscreen of SPF 30 or higher. TriLuma Cream 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. Women who are pregnant, nursing or trying to become pregnant, should not use Tri-Luma. Safety and efficacy have not been established in individuals with darker skin (Fitzpatrick types V & VI). 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.

Company:

Galderma Laboratories, L.P.
817-961-5000
www.triluma.com