FDA label 482da66b-b0fa-1136-e054-00144ff8d46c

WARNING: For external use only.

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria

ADVERSE EVENTS Diosmin glycoside Many clinical trials have been conducted in adults with various manifestations of CVI to assess the efficacy of orally administered diosmin in doses ranging from 400 to 5,000 mg/day for up to a year. No serious adverse events were reported in any of the studies. Commonly reported adverse events included gastrointestinal disturbances and headaches; these were generally mild in severity and did not usually result in patients discontinuing participation in the study. The following adverse events (and approximate percentages) were reported in clinical trials but their frequency did not differ from placebo: rash (1%), cramping in lower limb (2%), phlebitis (2%), venous thrombosis (4%), and skin changes around existing ulcer, swelling of the extremities and body rash (1.6%). Dyspepsia, or non-specific mild stomach upset, occurred in up to 7% of subjects taking diosmin at various doses and was seen with approximately twice the frequency seen in the placebo groups. Rare adverse events include inguinal pain, cystitis, asthenia, metrorrhagia and menometrorrhagia. In clinical trials, the incidence of adverse events in elderly populations (≥70 years of age) was not significantly different from that in younger populations nor were adverse events higher in patients with concomitant hypertension, atherosclerosis, diabetes, neurologic/psychiatric disease or alcoholism. Alka4-complex The case histories for 18 subjects who consumed ~3 g/day of alka4-complex for 18 months were analyzed and found to contain no reports of adverse events.

<table width="450" styleCode="Noautorules"> <tbody> <tr> <td>Burning</td> <td>Hypertrichosis</td> <td>Maceration of the skin</td> </tr> <tr> <td>Itching</td> <td>Acneiform eruptions</td> <td>Secondary infection</td> </tr> <tr> <td>Irritation</td> <td>Hypopigmentation</td> <td>Skin atrophy</td> </tr> <tr> <td>Dryness</td> <td>Perioral dermatitis</td> <td>Striae</td> </tr> <tr> <td>Folliculitis</td> <td>Allergic contact dermatitis</td> <td>Miliaria</td> </tr> </tbody> </table>