Home FDA labels 51d90d5f-037f-488b-8e8e-fe31570d23e9 FDA label 51d90d5f-037f-488b-8e8e-fe31570d23e9 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 dc8549bd-eb87-4520-bc1f-9890055659b4
SPL ID 51d90d5f-037f-488b-8e8e-fe31570d23e9
Version 13
Effective date 2020-01-17
Source export date 2026-10-12
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-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 Aktipak ® . 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% of 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 Aktipak ® N = 236 Aktipak ® 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%"> <colgroup> <col width="24%"/> <col width="15%"/> <col width="15%"/> <col width="16%"/> <col width="21%"/> </colgroup> <thead> <tr> <th styleCode="Toprule" align="left" valign="top"/> <th styleCode="Toprule" colspan="4" align="left" valign="top"> <content styleCode="bold">Treatment Group Summaries</content> <content styleCode="bold">Number of Patients (%)</content> </th> </tr> <tr> <th styleCode="Botrule" align="left" valign="top"> <content styleCode="bold">COSTART Term</content> </th> <th styleCode="Botrule Lrule" align="left" valign="top"> <content styleCode="bold">Aktipak<sup>®</sup> </content> <content styleCode="bold">N = 236</content> </th> <th styleCode="Botrule" align="left" valign="top"> <content styleCode="bold">Aktipak<sup> ®</sup> </content> <content styleCode="bold">Vehicle</content> <content styleCode="bold">N = 153</content> </th> <th styleCode="Botrule" align="left" valign="top"> <content styleCode="bold">Benzamycin</content> <content styleCode="bold">Topical Gel</content> <content styleCode="bold">N = 121</content> </th> <th styleCode="Botrule Rrule" align="left" 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="Botrule Lrule Toprule"> <paragraph>DRY SKIN</paragraph> </td> <td styleCode="Botrule Lrule Toprule"> <paragraph>18 (7.6%)</paragraph> </td> <td styleCode="Botrule Lrule Toprule"> <paragraph>6 (3.9%)</paragraph> </td> <td styleCode="Botrule Lrule Toprule"> <paragraph>6 (5.0%)</paragraph> </td> <td styleCode="Botrule Lrule Rrule Toprule"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule"> <paragraph>APPLICATION SITE REACTION (stinging, erythema, and burning)</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>6 (2.5%)</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>2 (1.3%)</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>1 (0.8%)</paragraph> </td> <td styleCode="Botrule Lrule Rrule"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule"> <paragraph>BLEPHARITIS</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>4 (1.7%)</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>1 (0.7%)</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>0</paragraph> </td> <td styleCode="Botrule Lrule Rrule"> <paragraph>1 (2.5%)</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule"> <paragraph>PRURITUS</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>4 (1.7%)</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>2 (1.3%)</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>3 (2.5%)</paragraph> </td> <td styleCode="Botrule Lrule Rrule"> <paragraph>0</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule"> <paragraph>PHOTOSENSITIVITY REACTION (Sunburn, stinging with sun exposure)</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>3 (1.3%)</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>0</paragraph> </td> <td styleCode="Botrule Lrule"> <paragraph>0</paragraph> </td> <td styleCode="Botrule Lrule Rrule"> <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="Botrule Lrule Rrule"> <paragraph>0</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.