References:
1. Aktipak™ (erythromycin and benzoyl peroxide) Gel, 3%/5% [package insert]. Wayne, PA: Cutanea Life Sciences, Inc.; 2017. 2. Data on file. Cutanea Life Sciences, Inc. 2017.
AKT023b 02/2019 ©2019 Dermarc, LLC, a wholly owned subsidiary of Cutanea Life Sciences, Inc. All rights reserved.
All product names or other trademarks included herein are trademarks of Dermarc, LLC, a wholly owned subsidiary of Cutanea Life Sciences, Inc., unless otherwise noted. All rights reserved.

INDICATIONS AND USAGE
AKTIPAK™ (erythromycin and benzoyl peroxide) Gel, 3%/5% is indicated for the topical treatment of acne vulgaris.
IMPORTANT SAFETY INFORMATION
Contraindications: AKTIPAK™ is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Precautions: For topical use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating or abrasive agents. If severe irritation develops, discontinue use and institute appropriate therapy. The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms. If this occurs, discontinue use and take appropriate measures. Avoid contact with eyes and all mucous membranes.
Pregnancy: It is not known whether AKTIPAK™ can cause fetal harm when administered to a pregnant woman. AKTIPAK™ should be given to a pregnant woman only if clearly needed. It is not known whether the ingredients of AKTIPAK™ are excreted in human milk. Therefore, caution should be exercised when erythromycin is administered to a nursing woman.
Pediatric Use: The safety and effectiveness of AKTIPAK™ in pediatric patients below 12 years of age have not been established.
Adverse Reactions: The most frequently reported adverse events reported in clinical trials include: dry skin, application site
reaction, blepharitis, pruritus, and photosensitivity.
Please see accompanying full Prescribing Information and Important Safety Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/Safety/MedWatch/default.htm or call
1-800-FDA-1088.
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PRIVACY POLICY
Welcome to www.aktipak.com (also referred to as “Site”) owned and operated by Cutanea Life Sciences, Inc. or one of its subsidiary entities (also referred to as “Cutanea”, “us,” or “we”). This Privacy Policy is designed to tell you (“you” or “your”) about our practices regarding collection, use, and disclosure of information that you provide or that is collected through this Site. This Privacy Policy does not apply to information collected from you through offline means or from Cutanea websites that do not link to this Privacy Policy, with the following exception – if we merge information collected about you through offline means or from other Cutanea websites with information collected through this Site, then the collection, use and disclosure of such merged information will be governed by the terms of this Privacy Policy for so long as it is so merged.
Please be sure to read this Privacy Policy before using or submitting information to this Site. This Privacy Policy is the sole authorized statement of Cutanea’s practices concerning the collection, use and protection of personal information through this Site.
Your Agreement and Consent
By using this Site you agree to the terms of this Privacy Policy and you consent to the collection, use and disclosure of information in accordance with this Privacy Policy.
Definition of “Personal Information”
As used in this Privacy Policy, “personal information” means information that identifies you or is identifiable to you.
Information You Provide and We Collect
Some areas of this Site may ask you to submit personal information in order for you to benefit from the specified features or to participate in a particular activity. When we collect personal information, we clearly label the information we are collecting. You have the sole and absolute discretion as to whether to provide personal information to us.
Passive Information Collection
As you navigate through this Site, we may passively collect (that is, gather without your actively providing the information) certain non-personal information using various technologies and means, such as internet protocol addresses, cookies, internet tags, web beacons and navigational data collection. For example, your internet browser automatically transmits to this Site some of this unidentifiable information, such as the URL of the website you just came from, the internet protocol (IP) address, and the browser version your computer is currently using. This Site may also collect unidentifiable information from your computer through cookies, internet tags, web beacons or other means. You may set your browser to notify you when a cookie is sent or to refuse cookies altogether, but certain features of this Site might not work without cookies. Also, our website does not accept do not track signals from a web browser. We may aggregate and use personal information in such a way that it cannot be identified to you.
Use and Disclosure of Information
We may use information collected through this Site to improve the content of the Site, to communicate with you, for our marketing and research purposes, and for any other purpose specified at the time the information is collected. In addition, we may use and disclose to others non-personal information collected through this Site without any restrictions.
In some instances, we may remove personal identifiers from data and maintain it as non-personal information. We also we may combine non-personal information with personal information. If we do combine any non-personal information with personal information, the combined information will be treated as personal information under this Privacy Policy as long as it is so combined. We may disclose personal information you provide through this Site to other Cutanea affiliates that agree to treat it in accordance with this Privacy Policy. We also may disclose personal information you provide through this Site to third parties that are not Cutanea affiliates, but only:
- to agents, contractors and third-party partners we use to support our business, in which case we will seek to restrict such third parties’ use of such data to the purposes for which it has been provided; provided, however, that Cutanea shall not be responsible for third parties’ unauthorized uses, disclosures or other violations of this Privacy Policy or any other rights of users of this Site; or
- to a purchaser or successor entity in connection with the sale, merger, assignment, or other transfer of Cutanea or any of its affiliates, or line of business or product of Cutanea or any of its affiliates, or sale of substantially all of Cutanea or any of its affiliates; or
- to respond to law enforcement requests or where we determine that disclosure is required by applicable laws, court orders, or government regulations; or
- to enforce our Terms of Use; to protect our operations; to protect the rights, privacy, safety or property of Cutanea, you or others; or to permit us to pursue available remedies or limit the damages that we may sustain;
- if you have consented to the disclosure; or
- for research or to improve our products or services
Please be advised that the collection, use, and disclosure of information contemplated in this Privacy Policy may involve a transfer of the information to jurisdictions located outside your country of residence that may not have equivalent laws and rules regarding personal information.
No Third-Party Direct Marketing Use
Cutanea will not sell or otherwise transfer the personal information you provide us at this Site to any third parties for their own direct marketing use unless we have obtained your explicit consent for your data to be shared in this manner.
Personal Information Protection
We take measures designed to prevent unauthorized intrusion to this Site and the alteration, acquisition or misuse of personal information, however, we will not be responsible for loss, corruption or unauthorized acquisition or misuse of personal information that you provide through this Site or that is stored by us, or for any damages resulting from such loss, corruption or unauthorized acquisition or misuse.
Other Websites
This Site may contain links or references to other websites. Please be aware that we do not control and are not in any way responsible for these linked websites and that this Privacy Policy does not apply to those websites. We encourage you to read the privacy policy of every website you visit as that will govern the collection, use and disclosure of your information.
About Children
This Site is not intended for or designed to attract children under the age of 18. We will not knowingly collect or maintain personal information through this Site from visitors in this age group. If you are a parent and you become aware that your child has provided us with information, please contact us as specified below, and we will work with you to address this issue.
Correction and Deletion of Personal Information
To keep personal information that you provide through this Site accurate, current and complete, please contact us as specified below and we will take appropriate steps to update or correct such information in our possession, or to delete your personal information from our contact list.
If you request that we delete your personal information, please note that we may need to retain certain personal information for record-keeping purposes, and there may also be residual personal information that will remain within our databases and other records, which will not be removed therefrom. We are not responsible for removing personal information from the databases of third parties with whom we have already shared your personal information as permitted by this Privacy Policy and shall not be responsible for any damages resulting the loss, corruption or unauthorized acquisition or misuse of such personal information.
How to Contact Us
If you have questions, comments, or concerns about this Privacy Policy or the information practices of this Site, or if you would like to opt-out of future communications, please contact us by sending a letter to:
Cutanea Life Sciences, Inc.
1500 Liberty Ridge Drive
Suite 3000
Wayne, PA 19087
Attention: General Counsel
Privacy Policy Updates
Please note that Cutanea reserves the right to revise this Privacy Policy at any time at our sole discretion. Therefore, you are urged to review the Privacy Policy each time you access this Site to ensure that you are familiar with the most current version. Use of this Site following such modification constitutes your acceptance of the revised Privacy Policy then in effect.
This Privacy Policy was last updated on 4/28/2016. [Effective Date]
Terms of Use
BEFORE ACCESSING THIS SITE, PLEASE READ THE FOLLOWING TERMS OF USE CAREFULLY AS THEY GOVERN YOUR USE OF THIS SITE. IF YOU DO NOT AGREE WITH THESE TERMS OF USE, YOU ARE NOT GRANTED PERMISSION TO ACCESS OR OTHERWISE USE THIS SITE. YOU SHOULD REVIEW THESE TERMS EACH TIME YOU ACCESS THIS SITE AS THEY MAY CHANGE AT ANY TIME AT OUR SOLE DISCRETION.
www.aktipak.com. User Agreement
Welcome to www.aktipak.com (also referred to as “Site”), owned and operated by Cutanea Life Sciences, Inc. or one of its subsidiary entities (also referred to as “Cutanea”, “us” or “we”). This Site and its content are for general informational purposes and intended strictly for access and use by United States residents. These Terms of Use govern your access and use of this Site. By accessing or using this Site, you indicate that you understand and intend these Terms of Use to be the legal equivalent of a signed, written contract and equally binding, and that you accept such Terms of Use and agree to be legally bound by them. Please note that Cutanea reserves the right to change these Terms of Use at any time at its sole discretion. Your continued use of this Site following any such modifications will be conclusively deemed acceptance of any changes to these Terms of Use. Therefore, you are urged to review the Terms of Use each time you access this Site.
License Grant
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Medical Information
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Links to Other Websites
This Site may link you to other websites that are not owned or controlled by Cutanea. The fact that we provide a link to a third party website does not mean that we endorse, authorize or sponsor that website. It also does not mean that we are affiliated with the third party website’s owners or sponsors. These links are provided for your convenience only. Cutanea expressly disclaims any responsibility for the content, the accuracy of the information, the quality of products or services provided by or advertised on these third-party sites and /or the collection and use of personally identifiable information by these third-party sites. If you choose to hyperlink to another website, You do so at your own risk. We reserve the right to terminate a link to a third party website at any time.
Links from Other Websites to this Site
If a third party links to this Site, it is not necessarily an indication of an endorsement, authorization, sponsorship, affiliation, joint venture or partnership by or with us. In most cases, we are not aware that a third party has linked to this Site. Cutanea expressly disclaims any responsibility for the content, the accuracy of the information, the quality of products or services provided by or advertised on these third-party sites and/or the collection and use of personally identifiable information by these third-party sites.
Forward-Looking Statements
This Site contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained on this Site that are not historical facts are hereby identified as forward-looking statements for this purpose. Forward-looking statements generally can be identified by words such as “may,” “will,” “shall,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” and similar expressions , although not all forward-looking statements contain these identifying words. Forward-looking statements are based upon our current expectations and beliefs and are subject to risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, but are not limited to, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries. In light of the significant uncertainties in forward-looking statements, you should not regard such statements as a representation or warranty that we will achieve our objectives and plans in any specified timeframe, and you should not place undue reliance on any forward-looking statements. While we may update certain forward-looking statements from time to time, we specifically disclaim any obligation to do so, whether as a result of new information, future developments or otherwise.
Submissions
Cutanea welcomes your feedback and suggestions about how to improve this Site. Any ideas, suggestions, information, know-how, material, or other content (collectively, “content”) received through this Site, however, will be deemed to include a royalty-free, perpetual, irrevocable, transferable, worldwide, nonexclusive right and license for Cutanea to adopt, publish, reproduce, disseminate, transmit, distribute, copy, use, create derivative works, display (in whole or part), or act on such content without additional approval or consideration, in any form, media, or technology now known or later developed for the full term of any rights that may exist in such content. Subject to our “Privacy Policy” (as defined below), if you transmit to or post on this Site any material, data, information or idea by any means, unless otherwise agreed by Cutanea, it will be treated as non-confidential and non-proprietary and may be disseminated or used by us for any purpose. You are not authorized to post on or transmit to or from this Site any unlawful, threatening, libelous, defamatory, obscene, scandalous, inflammatory, pornographic, or profane material, or any other content that could give rise to any civil or criminal liability under the law.
Intellectual Property Rights
All materials contained on this Site are protected by law, including but not limited to United States patent, copyright, trademark and trade secret law, as well as other state, national, and international laws and regulations. The contents of and all materials distributed in conjunction with this Site are Copyright © 2016 Dermarc, LLC, a wholly owned subsidiary of Cutanea Life Sciences, Inc., or its licensors, all rights reserved. Cutanea also owns a copyright in this Site as a collective work and/or compilation, and in the selection, coordination, arrangement, and enhancement of such content. The Cutanea name and logo and “Aktipak” whether or not appearing with a trademark symbol, are trademarks of Dermarc, LLC, a wholly owned subsidiary of Cutanea Life Sciences, Inc. Unauthorized use of any material or trademarks contained on this Site may violate copyright laws, trademark laws, the laws of privacy and publicity, communications regulations and statutes and other laws and regulations. Please be aware that Cutanea actively and aggressively enforces its intellectual property rights to the fullest extent of the law. Copyright Owners’ Rights Under the Digital Millennium Copyright Act Of 1998 The Digital Millennium Copyright Act of 1998 (the “DMCA”) provides recourse for copyright owners who believe that material appearing on the internet infringes their rights under United States copyright law. If you believe in good faith that materials hosted by Cutanea infringe your copyright, you (or your agent) may send us a notice requesting that the materials be removed, or access to them blocked. If you believe in good faith that a notice of copyright infringement has been wrongly filed against you, the DMCA permits you to send us a counter-notice.
Notices and counter-notices must meet statutory requirements imposed by the DMCA. One place to find more information on the DMCA is the U.S. Copyright Office website. Notices and counter-notices for the Site should be sent to General Counsel, Cutanea Life Sciences, Inc., 1500 Liberty Ridge Drive, Suite 3000, Wayne, PA 19087.
Limitation of Liability
YOU ASSUME FULL RESPONSIBILITY AND ALL RISKS ARISING FROM ACCESS AND USE OF THIS SITE AND THE EMAIL ALERT SERVICE AVAILABLE THROUGH THIS SITE. IN NO EVENT SHALL CUTANEA OR ITS AFFILIATES, OR ANY OF THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, SHAREHOLDERS, AGENTS, REPRESENTATIVES, SERVICE PROVIDERS OR LICENSORS, OR THEIR RESPECTIVE SUCCESSORS AND ASSIGNS, BE LIABLE FOR ANY DAMAGES OF ANY KIND OR NATURE (WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE), INCLUDING BUT NOT LIMITED TO DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL (INCLUDING LOSS OF PROFITS), PUNITIVE OR OTHER DAMAGES, ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE EXISTENCE, ACCESS OR USE OF THIS SITE OR THE EMAIL ALERT SERVICE, REGARDLESS OF WHETHER CUTANEA OR ANY OF THE OTHER ENTITIES OR PERSONS LISTED ABOVE HAS BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES.
Indemnification
You agree to indemnify, defend and hold harmless Cutanea and/or its affiliates, and their respective officers, directors, employees, shareholders, agents, representatives, service providers and licensors, and their respective successors and assigns, from and against any damages (including reasonable attorneys’ and professional fees’ and litigation costs) arising out of or related to your breach of these Terms of Use or your misuse of this Site.
Privacy Policy
The privacy policy governing this Site is located at http://www.aktipak.com (“Privacy Policy”). The Privacy Policy is incorporated by reference into, and is a part of, these Terms of Use. By using this Site you agree to the terms of the Privacy Policy and you consent to the collection, use and disclosure of information in accordance with the Privacy Policy. Please be sure to read the Privacy Policy before using or submitting information to this Site.
Miscellaneous
THESE TERMS OF USE SHALL BE GOVERNED BY THE LAWS OF THE COMMONWEALTH OF PENNSYLVANIA, WITHOUT REGARD TO CONFLICTS OF LAW RULES, AND THE EXCLUSIVE JURISDICTION AND VENUE FOR ANY DISPUTE SHALL BE THE COMMONWEALTH OF PENNSYLVANIA. Our failure to insist upon or enforce strict performance of any provision of these Terms of Use shall not be construed as a waiver of any provision or right. Neither the course of conduct between the parties nor trade practice shall act to modify any provision of these Terms of Use. We may assign or transfer our rights and duties under these Terms of Use to any party at any time without notice to you.
These Terms of Use were last updated on 1/3/2017. [Effective Date.]
INDICATIONS AND USAGE
AKTIPAK™ (erythromycin and benzoyl peroxide) Gel, 3%/5% is indicated for the topical treatment of acne vulgaris.
IMPORTANT SAFETY INFORMATION
Contraindications: AKTIPAK™ is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Precautions: For topical use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution
because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating or abrasive agents.
If severe irritation develops, discontinue use and institute appropriate therapy. The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms. If this occurs, discontinue use and take appropriate measures. Avoid contact with eyes and all mucous membranes.
Pregnancy: It is not known whether AKTIPAK™ can cause fetal harm when administered to a pregnant woman. AKTIPAK™ should be given to a pregnant woman only if clearly needed. It is not known whether the ingredients of AKTIPAK™ are excreted in human milk. Therefore, caution should be exercised when erythromycin is administered to a nursing woman.
Pediatric Use: The safety and effectiveness of AKTIPAK™ in pediatric patients below 12 years of age have not been established.
Adverse Reactions: The most frequently reported adverse events reported in clinical trials include: dry skin, application site
reaction, blepharitis, pruritus, and photosensitivity.
Please see accompanying full Prescribing Information and Important Safety Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/Safety/MedWatch/default.htm or call
1-800-FDA-1088.
CONTACT US
- druginfo@cutanea.com
-
- Cutanea Life Sciences, Inc.
- 1500 Liberty Ridge Drive,
- Suite 3000
- Wayne, PA 19087