FDA label 7afd87aa-acc7-459e-8c50-a6e663a3455e

ADVERSE REACTIONS The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Derma-Smoothe/FS ® . A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of Derma-Smoothe/FS ® when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events ). Incidence of Adverse Events (%) N=58 Adverse Event (AE) The number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse event. # of patients (%) Day 14 Day 28 End of Treatment Day 56 Four Weeks Post Treatment Any AE 15 (25.9) 6 (10.3) 7 (12.1) 7 (12.1) Telangiectasia 5 (8.6) 3 (5.2) 4 (6.9) 2 (3.5) Erythema 3 (5.2) 3 (5.2) Itching 3 (5.2) 3 (5.2) Irritation 3 (5.2) 3 (5.2) Burning 3 (5.2) 3 (5.2) Hypopigmentation 2 (3.5) 2 (3.5) Shiny Skin 1 (1.7) 1 (1.7) Secondary atopic dermatitis 1 (1.7) 1 (1.7) Papules and pustules 1 (1.7) 1 (1.7) Keratosis pilaris 1 (1.7) 1 (1.7) Folliculitis 1 (1.7) 1 (1.7) Facial herpes simplex 1 (1.7) 1 (1.7) Acneiform eruption 1 (1.7) 1 (1.7) Ear infection 1 (1.7) 1 (1.7)

<table width="80%" ID="table1"> <caption>Incidence of Adverse Events (%) N=58</caption> <col width="40%" align="left" valign="top"/> <col width="15%" align="center" valign="top"/> <col width="15%" align="center" valign="top"/> <col width="15%" align="center" valign="top"/> <col width="15%" align="center" valign="top"/> <thead> <tr> <th styleCode="Lrule" align="center">Adverse Event (AE)<footnote> <content styleCode="bold">The number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse event.</content> </footnote> </th> <th styleCode="Lrule"># of patients (%)</th> <th styleCode="Lrule">Day 14</th> <th styleCode="Lrule">Day 28<footnote> <content styleCode="bold">End of Treatment</content> </footnote> </th> <th styleCode="Lrule Rrule">Day 56<footnote> <content styleCode="bold">Four Weeks Post Treatment</content> </footnote> </th> </tr> </thead> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule">Any AE</td> <td styleCode="Lrule">15 (25.9)</td> <td styleCode="Lrule">6 (10.3)</td> <td styleCode="Lrule">7 (12.1)</td> <td styleCode="Lrule Rrule">7 (12.1)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Telangiectasia</td> <td styleCode="Lrule">5 (8.6)</td> <td styleCode="Lrule">3 (5.2)</td> <td styleCode="Lrule">4 (6.9)</td> <td styleCode="Lrule Rrule">2 (3.5)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Erythema</td> <td styleCode="Lrule">3 (5.2)</td> <td styleCode="Lrule"/> <td styleCode="Lrule"/> <td styleCode="Lrule Rrule">3 (5.2)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Itching</td> <td styleCode="Lrule">3 (5.2)</td> <td styleCode="Lrule"/> <td styleCode="Lrule"/> <td styleCode="Lrule Rrule">3 (5.2)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Irritation</td> <td styleCode="Lrule">3 (5.2)</td> <td styleCode="Lrule"/> <td styleCode="Lrule"/> <td styleCode="Lrule Rrule">3 (5.2)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Burning</td> <td styleCode="Lrule">3 (5.2)</td> <td styleCode="Lrule"/> <td styleCode="Lrule"/> <td styleCode="Lrule Rrule">3 (5.2)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Hypopigmentation</td> <td styleCode="Lrule">2 (3.5)</td> <td styleCode="Lrule">2 (3.5)</td> <td styleCode="Lrule"/> <td styleCode="Lrule Rrule"/> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Shiny Skin</td> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule"/> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule Rrule"/> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Secondary atopic dermatitis</td> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule"/> <td styleCode="Lrule"/> <td styleCode="Lrule Rrule">1 (1.7)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Papules and pustules</td> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule"/> <td styleCode="Lrule"/> <td styleCode="Lrule Rrule">1 (1.7)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Keratosis pilaris</td> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule"/> <td styleCode="Lrule"/> <td styleCode="Lrule Rrule">1 (1.7)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Folliculitis</td> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule"/> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule Rrule"/> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Facial herpes simplex</td> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule"/> <td styleCode="Lrule Rrule"/> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Acneiform eruption</td> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule"/> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule Rrule"/> </tr> <tr> <td styleCode="Lrule">Ear infection</td> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule"/> <td styleCode="Lrule">1 (1.7)</td> <td styleCode="Lrule Rrule"/> </tr> </tbody> </table>