Introducing 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.

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Item Number

2000997

Item
‍

lidocaine, EPINEPHrine, tetracaine
Sterile Topical Gel

Presentation

Single-Use Syringe

Concentration

4% / 0.18% / 0.5%

Container Size

5 mL Syringe

Fill Volume

3 mL

Expiry Dating

90 Days

NDC (71266)

6290-01

You care about patient safety, which is why you need the new Sterile Topical L.E.T. Gel

In a 2019 Food and Drug Administration (FDA) warning, the agency shared significant concerns and dangers of using non-sterile anesthetic for wound care. An FDA approved recall notification states:

“… 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.”

FSS leveraged pharmaceutical expertise spanning three decades to quickly develop the first Sterile Topical LET Gel in the industry – listening to both customer needs and the FDA. Other suppliers continue to offer non-sterile LET Gel at risk.

A topically applied analgesic solution containing lidocaine–EPINEPHrine–tetracaine with vasoconstrictive properties provides safe and effective pain control during wound repair using sutures.

Source: Eidelman A, Weiss JM, Baldwin CL, et al.Topical anaesthetics for repair of dermal laceration.Cochrane Database Syst Rev2011; (6):CD005364.

Treating minor lacerations with lidocaine–epinephrine–tetracaine before wound closure with tissue adhesive reduced ratings of pain and increased the proportion of pain-free repairs among children aged 3 months to 17 years.

Source: Stuart Harman, Roger Zemek, Mary Jean Duncan, Yvonne Ying and William Petrcich CMAJ September 17, 2013 185 (13) E629-E634;

LET gel [...] possesses theoretical advantages for topical anesthesia during suturing of uncomplicated lacerations on the face and scalp in children.

Source: Ann Emerg Med December 1998; 32:693-697

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 US, 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. Committed Supply Program customers enjoy greater than 97% same-day fill rate on orders placed before cut-off times

100% Tested

All batches must successfully pass tests for sterility, particulate matter and potency prior to being released

Customer is number 1

Speed of execution

Quality

Creativity

Entrepreneurship

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

About Fagron Sterile Services US

FSS, a top-tier DEA and FDA-registered 503B Outsourcing Provider, produces reliable supply of high-quality sterile medications with cGMP compliant operations, for patient-focused healthcare facilities across North America.

FSS’ team employs expertise in legal and regulatory compliance, pharmaceutical manufacturing, and repackaging, leveraging industry leading automation, advanced environmental monitoring, and sophisticated in-house quality testing labs.