Introducing the first Sterile Topical L.E.T. Gel from a 503B outsourcing facility
Sterile Topical 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.”
A topically applied analgesic solution containing lidocaine–EPINEPHrine–tetracaine with vasoconstrictive properties provides safe and effective pain control during wound repair using sutures.
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.
LET gel [...] possesses theoretical advantages for topical anesthesia during suturing of uncomplicated lacerations on the face and scalp in children.
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.
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.
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