The first Sterile Topical L.E.T. Gel from a 503B outsourcing facility
LET Gel is a topical anesthetic consisting of Lidocaine, EPINEPHrine, and Tetracaine which is commonly used in conjunction with suturing patients in hospital emergency rooms, urgent care centers, pediatrician offices or by other qualified health care providers.
You care about patient safety, which is why you need the new Sterile Topical L.E.T. Gel
“… non-sterile product has the potential to result in an increased chance of infection at the site of administration during open wound care. The use of this or other non-sterile products in wound treatment may increase the risk of infection, especially for immunocompromised patients, the elderly, or children.”
Sterile Topical L.E.T. Gel
FSS worked tirelessly to develop the first sterile version of a topical LET gel, listening to both customer needs and the FDA.
Sterile Topical LET Gel, from Fagron Sterile Services, is the only product of its kind on the market from a 503B outsourcing facility or compounding pharmacy.
FDA / DEA Registered & Inspected
Compliance with FDA, DEA, cGMP, GDP and cGLP regulations and guidance ensure our process is sound and supports patient safety
cGMP Compliant
Three decades of experience employing subject matter expertise with 21 CFR Parts 210 and 211 produces quality you can trust
ISO 5 environments
16 independent aseptic processing environments with dedicated HVAC systems, automation and depyrogenation technology
Committed Supply
The medication you want, when you need it — period. Talk with an Account Representative today about our Instant Ship program
100%Tested
All batches must successfully pass tests for sterility, particulate matter and potency prior to being released
Prepared in a world-class ISO 5 sterile environment
Subject matter experts from FSS’ Laboratory Services, Validation, Operations, and Quality collaborated to ensure the consistency of a sterile gel by employing a sophisticated, multi-step, process validation and following cGMP compliant operations at FSS’ state-of-the-art facilities, centrally located in Wichita, KS.
The manufacturing process of Sterile Topical LET Gel has been fully validated with Aseptic Process Simulation (Media Fill) and Stability Studies proving product efficacy throughout the life of its expiry date.
No refrigeration required
FSS recognized refrigerated storage space may be limited for many healthcare facilities. Unlike traditional, non-sterile LET Gel, FSS' innovative Sterile Topical LET Gel does not require refrigeration to achieve Beyond Use Dating (BUD). Conveniently store the preparation at room temperature (20°C to 25°C) and save on limited refrigeration space.
FSS dispenses Sterile Topical LET Gel in a convenient 3 mL unit dose syringe, available in 10-packs. As a 503B Outsourcing Facility, FSS can distribute LET Gel for shelf stock, no need for patient specific prescriptions.
Advanced labeling with multiple route of administration safety warnings
Patient safety is critical. That is why every dose of FSS' Sterile Topical LET Gel is individually labeled and includes multiple safety warnings in different orientations to help minimize the risk of misadministration, including a "Topical Use Only" sticker over the tamper-evident cap.
FSS' product labels clearly display critical information:
• Presentation specifications
• Route of administration
• Storage requirements
• Expiration dating
• TALLman lettering
• Barcode
Together we create the future of personalizing medicine.
Over the past 34 years, Fagron has earned the trust of pharmacists in communities across more than 30 countries by prioritizing transparency and delivering high-quality medications supporting patient care.
Fagron Sterile Services US (FSS) is a DEA and FDA-registered and inspected supplier, providing a broad portfolio of high-quality sterile medication and expertise in pharmaceutical manufacturing, repackaging, patient safety, regulatory guidance and pharmacy.
234,000 ft²
Capacity across 3 state-of-the art operational facilities
100%
of batches tested for sterility, particulate matter and potency to support patient safety
Diverse product portfolio
Supporting providers and the patients you serve across the continuum of care
Instant ship program
Medications when you need them the most, in-stock, ready to ship
Speak with your personal representative today
Service is in our name and we can’t wait to partner with your patient-focused healthcare facility. Schedule a free consultation today to discuss your 503B outsourcing needs.
Globally and vertically integrated operations
Fagron’s 4k+ employees serve 30+ countries from 70+ facilities
Proactively supporting supply chain resiliency
Fagron’s global team of 100 supply chain experts leverage 3k+ suppliers
Diverse portfolio across the continuum of care
FSS supports patient care from the delivery room to the O.R.
including clinics
