FDA label 772de3d1-9400-4011-a4ec-200651cabcb5

WARNINGS Avoid fire, flame, or smoking during and immediately following application of XOLEGEL Gel.

ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Overall Summary of Adverse Events Reported by >1% of Subjects Table 2 NOTE: The same adverse event recorded by a subject at different visits count as one event for that subject, and the strongest intensity and relationship to treatment is used. At each level of summarization (System Organ Class and Preferred Term) subjects are only counted once. Adverse Event XOLEGEL Gel N=545 N (%) Gel Vehicle N=388 N (%) Any Adverse Event 89 (16.3) 67 (17.3) Application site burning 23 (4.2) 12 (3.1) Headache 6 (1.1) 3 (0.8) In the three safety and efficacy studies, 65 of 933 subjects (7%) experienced at least one treatment-related adverse event. The most common treatment-related adverse event was application site burning (see Table 2). Treatment-related application site reactions that were reported in < 1% of subjects were: dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, and pustules. Other treatment-related adverse reactions that were reported in < 1% of subjects were: eye irritation, eye swelling, keratoconjunctivitis sicca, impetigo, pyogenic granuloma, dizziness, headache, paresthesia, acne, nail discoloration, facial swelling. Contact sensitization, cumulative irritation, phototoxicity and photoallergy studies were conducted with XOLEGEL Gel. Under the conditions of study, XOLEGEL Gel did not demonstrate contact sensitization, phototoxicity or photoallergenicity, but did demonstrate potential to cause irritation.

<table width="0.000" ID="id_9211f768-11a6-488f-bb73-79ed477c444a"> <caption ID="id_5a4d0582-fee2-4514-bc3d-65195e72214f">Table 2</caption> <col/> <col/> <col/> <tfoot ID="id_c834ed47-4d6b-43e7-b208-597b2bdd3681"> <tr> <td align="left" valign="top" colspan="3"> <paragraph>NOTE: The same adverse event recorded by a subject at different visits count as one event for that subject, and the strongest intensity and relationship to treatment is used. At each level of summarization (System Organ Class and Preferred Term) subjects are only counted once.</paragraph> </td> </tr> </tfoot> <tbody> <tr ID="id_99464932-f517-42a0-a078-5f177bf7447e" styleCode="Toprule"> <td align="left" valign="top">Adverse Event</td> <td align="center" valign="top" styleCode="Toprule"> <paragraph>XOLEGEL Gel N=545</paragraph> <paragraph>N (%)</paragraph> </td> <td align="center" valign="top"> <paragraph>Gel Vehicle</paragraph> <paragraph>N=388</paragraph> <paragraph>N (%)</paragraph> </td> </tr> <tr ID="id_5bd5f753-7a74-439e-8dc8-e38bdb850d4e"> <td align="left" valign="top">Any Adverse Event</td> <td align="center" valign="top">89 (16.3)</td> <td align="center" valign="top">67 (17.3) </td> </tr> <tr ID="id_0d926044-d75b-4763-84a4-d78fd2c02df5"> <td align="left" valign="top">Application site burning</td> <td align="center" valign="top">23 (4.2)</td> <td align="center" valign="top">12 (3.1)</td> </tr> <tr ID="id_d845edcf-1f77-4b9d-9630-207400946250"> <td align="left" valign="top">Headache</td> <td align="center" valign="top">6 (1.1)</td> <td align="center" valign="top">3 (0.8)</td> </tr> </tbody> </table>