FDA label 5c728957-def3-4f4d-b53c-bcfc4c2c4f81

WARNING FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C). Manufactured for Stiefel Laboratories, Inc. Coral Gables, FL 33134 USA For additional information visit www.luxiq.com Questions? Call 1-888-500-DERM (3376). Side effects may be reported to this number. 303203 P/N: xxxxxxxx Lixuq, VersaFoam-HF, VersaFoam-HF & Design, Stiefel, and Stiefel & Design are registered trademarks of Stiefel Laboratories, Inc. ©2009 Stiefel Laboratories, Inc.

ADVERSE REACTIONS The most frequent adverse event was burning/itching/stinging at the application site; the incidence and severity of this event were as follows: Incidence and severity of burning/itching/stinging Maximum severity Product Total incidence Mild Moderate Severe Luxíq Foam n=63 34 (54%) 28 (44%) 5 (8%) 1 (2%) Betamethasone valerate lotion n=63 33 (52%) 26 (41%) 6 (10%) 1 (2%) Placebo Foam n=32 24 (75%) 13 (41%) 7 (22%) 4 (12%) Placebo Lotion n=30 20 (67%) 12 (40%) 5 (17%) 3 (10%) Other adverse events which were considered to be possibly, probably, or definitely related to Luxíq occurred in 1 patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation; dryness; folliculitis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; secondary infection; skin atrophy; striae; and miliaria. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

<table> <col width="36%"/> <col width="17%"/> <col width="11%"/> <col width="11%"/> <col width="10%"/> <tbody> <tr> <td colspan="5" styleCode="Toprule "> <paragraph>Incidence and severity of burning/itching/stinging</paragraph> </td> </tr> <tr> <td/> <td/> <td colspan="3"> <paragraph>Maximum severity</paragraph> </td> </tr> <tr> <td rowspan="2"> <paragraph>Product</paragraph> </td> <td rowspan="2"> <paragraph>Total incidence</paragraph> </td> <td rowspan="2"> <paragraph>Mild</paragraph> </td> <td rowspan="2"> <paragraph>Moderate</paragraph> </td> <td> <paragraph>Severe</paragraph> </td> </tr> <tr> <td/> </tr> <tr> <td> <paragraph>Lux&#xED;q Foam n=63</paragraph> </td> <td> <paragraph>34 (54%)</paragraph> </td> <td> <paragraph>28 (44%)</paragraph> </td> <td> <paragraph>5 (8%)</paragraph> </td> <td> <paragraph>1 (2%)</paragraph> </td> </tr> <tr> <td rowspan="2"> <paragraph>Betamethasone valerate lotion n=63</paragraph> </td> <td rowspan="2"> <paragraph>33 (52%)</paragraph> </td> <td rowspan="2"> <paragraph>26 (41%)</paragraph> </td> <td rowspan="2"> <paragraph>6 (10%)</paragraph> </td> <td> <paragraph>1 (2%)</paragraph> </td> </tr> <tr> <td/> </tr> <tr> <td> <paragraph>Placebo Foam n=32</paragraph> </td> <td> <paragraph>24 (75%)</paragraph> </td> <td> <paragraph>13 (41%)</paragraph> </td> <td> <paragraph>7 (22%)</paragraph> </td> <td> <paragraph>4 (12%)</paragraph> </td> </tr> <tr> <td styleCode="Botrule "> <paragraph>Placebo Lotion n=30</paragraph> </td> <td styleCode="Botrule "> <paragraph>20 (67%)</paragraph> </td> <td styleCode="Botrule "> <paragraph>12 (40%)</paragraph> </td> <td styleCode="Botrule "> <paragraph>5 (17%)</paragraph> </td> <td styleCode="Botrule "> <paragraph>3 (10%)</paragraph> </td> </tr> </tbody> </table>