(NOTE: ALWAYS HANDLE USING ASEPTIC TECHNIQUE) WOUND BED PREPARATION & APPLICATION DRESSING CHANGES & REAPPLICATIONS 1. Prepare wound area using standard debridement methods to ensure the wound is free of debris and devitalized tissue. The wound may be surgically debrided to ensure the wound edges contain viable tissue. A small influx of blood may be permitted into the wound. 2. Remove the tip cap from the 3cc syri...
Storage and handling
Do not use if Package has been opened or damaged. Should be stored at a clean, dry location at ambient temperature.
1.Prepare wound area using standard debridement methods to ensure the wound is free of debris and devitalized tissue. The wound may be surgically debrided to ensure the wound edges contain viable tissue. A small influx of blood may be permitted into the wound.
2.Remove the tip cap from the 3cc syringe.
3.Attach the flexible injector tip securely to the syringe.
4.Slowly dispense Keroxx® Flowable Wound Matrix into the wound area. Avoid pressing tip directly against the wound bed to ensure proper flow of Keroxx® from the flexible injector. For easily visible wound areas a thin 1-3mm film covering is adequate.
5.After application, use an appropriate non-adherent occlusive dressing. Change dressing as necessary.
6.Frequency of dressing changes typically occur every 2-5 days, or as determined by the healthcare provider.
7.Once wound is cleansed using proper technique Keroxx® Flowable Wound Matrix may be reapplied.
8.Proceed with reapplication of appropriate non-adherent occlusive secondary dressing.
9.If clinical signs of infection, excessive redness, blistering or suspected allergic reaction occurs the Keroxx should not be reapplied and proper notification and documentation should be done.
CONTRADICATIONS
CONTRAINDICATIONS SECTION
Keroxx® should not be used in patients with known sensitivity to keratin. The device is not indicated for third degree burns.
ACTIVE INGREDIENT: Keratin
PRECAUTIONS
PRECAUTIONS SECTION
Do not reuse or re-sterilize. Do not use if package is open or tip cap is missing or not fully attached to syringe, or if package is unsealed. Use prior to expiration date.
STORAGE
STORAGE AND HANDLING SECTION
Do not use if Package has been opened or damaged. Should be stored at a clean, dry location at ambient temperature.
HOW SUPPLIED
HOW SUPPLIED SECTION
Keroxx® is supplied sterile, in single use kits containing one 3cc syringe with flowable wound matrix, one flexible injector.
SPL UNCLASSIFIED SECTION
Keroxx® 3cc syringe/unit NDC 71474-304-03
Manufactured for: Molecular Biologicals, LLC Pasadena, TX 77505 | 1-844-793-9933 By Keraplast Research, Ltd Gerald St. Lincoln, 7674 NZ
Keroxx® is a registered trademark of Molecular Biologicals, LLC. The product incorporates patented and /or patent pending technologies owned by Molecular Biologicals, LLC.
Issue Date 01Jan17 DWG005/9
PRINCIPAL DISPLAY PANEL - 3 cc Syringe Box
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
For Wounds & Burns Keroxx Flowable Wound Matrix Enriched With Bioactive Keratin
1X 3cc/unit NDC 71474-304-03 2.5gm/cc Topical use Only Rx Only
Keramatrix® is an absorbable matrix enriched with medical grade keratin that delivers Replicine™ bioactive keratin protein to a skin injury, wound, or burns, creating and maintaining a moisture rich environment for healing.