Home FDA labels adaee81c-6c20-4139-86d6-19ddd5d57c2b FDA label adaee81c-6c20-4139-86d6-19ddd5d57c2b openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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SPL set ID 8d678ed8-fbd5-4f1d-b1fe-7303cec99191
SPL ID adaee81c-6c20-4139-86d6-19ddd5d57c2b
Version 6
Effective date 2014-11-17
Source export date 2026-10-12
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
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adverse reactions ADVERSE REACTIONS During clinical trials, 550 acne patients were studied. Of these patients, 236 were treated with Benzamycin Pak. The most frequently reported adverse event considered at least possibly related was dry skin (7.6%) as compared to Vehicle (3.9%). Application site reactions (stinging, burning sensation, tingling, erythema) were reported in 2.5% of patients versus 1.3% for Vehicle patients. Blepharitis, pruritus and photosensitivity reactions were reported in <2% of patients who used the dual pouch product. Treatment Group Summaries Number of Patients (%) COSTART Term Benzamycin Pak N = 236 Benzamycin Pak Vehicle N = 153 Benzamycin Topical Gel N = 121 Benzamycin Topical Gel Vehicle N = 40 DRY SKIN 18 (7.6%) 6 (3.9%) 6 (5.0%) 0 APPLICATION SITE REACTION (stinging, erythema, and burning) 6 (2.5%) 2 (1.3%) 1 (0.8%) 0 BLEPHARITIS 4 (1.7%) 1 (0.7%) 0 1 (2.5%) PRURITUS 4 (1.7%) 2 (1.3%) 3 (2.5%) 0 PHOTOSENSITIVITY REACTION (Sunburn, stinging with sun exposure) 3 (1.3%) 0 0 0 PEELING 1 (0.5%) 1 (0.7%) 0 0
adverse reactions table <table width="100%"> <col width="24%"/> <col width="15%"/> <col width="15%"/> <col width="16%"/> <col width="21%"/> <thead> <tr> <th align="left" styleCode="Toprule " valign="top"/> <th align="left" colspan="4" styleCode="Toprule " valign="top"> <content styleCode="bold">Treatment Group Summaries</content> <content styleCode="bold">Number of Patients (%)</content> </th> </tr> <tr> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">COSTART Term</content> </th> <th align="left" styleCode="Lrule Botrule " valign="top"> <content styleCode="bold">Benzamycin</content> <content styleCode="bold">Pak</content> <content styleCode="bold">N = 236</content> </th> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">Benzamycin</content> <content styleCode="bold">Pak</content> <content styleCode="bold">Vehicle</content> <content styleCode="bold">N = 153</content> </th> <th align="left" styleCode="Botrule " valign="top"> <content styleCode="bold">Benzamycin</content> <content styleCode="bold">Topical Gel</content> <content styleCode="bold">N = 121</content> </th> <th align="left" styleCode="Rrule Botrule " valign="top"> <content styleCode="bold">Benzamycin</content> <content styleCode="bold">Topical Gel Vehicle</content> <content styleCode="bold">N = 40</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Lrule Toprule Botrule "> <paragraph>DRY SKIN</paragraph> </td> <td styleCode="Lrule Toprule Botrule "> <paragraph>18 (7.6%)</paragraph> </td> <td styleCode="Lrule Toprule Botrule "> <paragraph>6 (3.9%)</paragraph> </td> <td styleCode="Lrule Toprule Botrule "> <paragraph>6 (5.0%)</paragraph> </td> <td styleCode="Rrule Lrule Toprule Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph>APPLICATION SITE REACTION (stinging, erythema, and burning)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>6 (2.5%)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>2 (1.3%)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>1 (0.8%)</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph>BLEPHARITIS</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>4 (1.7%)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>1 (0.7%)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>0</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>1 (2.5%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph>PRURITUS</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>4 (1.7%)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>2 (1.3%)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>3 (2.5%)</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule "> <paragraph>PHOTOSENSITIVITY REACTION (Sunburn, stinging with sun exposure)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>3 (1.3%)</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>0</paragraph> </td> <td styleCode="Lrule Botrule "> <paragraph>0</paragraph> </td> <td styleCode="Rrule Lrule Botrule "> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule "> <paragraph>PEELING</paragraph> </td> <td styleCode="Botrule Lrule "> <paragraph>1 (0.5%)</paragraph> </td> <td styleCode="Botrule Lrule "> <paragraph>1 (0.7%)</paragraph> </td> <td styleCode="Botrule Lrule "> <paragraph>0</paragraph> </td> <td styleCode="Rrule Botrule Lrule "> <paragraph>0</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.