keroxx

Manufacturer
Molecular Biologicals, LLC
Effective date
2018-11-30
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:08

Label at a glance#

Productkeroxx
Active ingredientAMINO ACIDS, HAIR KERATIN
Label structure11 sections

Dosage and administration

(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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Flowable Wound Matrix

Rx Prescription Only
Single Use
Topical use Only

STERILER

C E
0 1 2 3

CAUTION

SPL UNCLASSIFIED SECTION

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician (or properly licensed Healthcare practitioner).

DESCRIPTION

DESCRIPTION SECTION

Keroxx® is an advanced wound care device comprised of a flowable wound matrix.

The flowable wound matrix provides a scaffold for cellular migration, proliferation and capillary growth.

It is supplied in single use kits containing one 3cc syringe with flowable wound matrix and one flexible injector.

INDICATIONS FOR USE

INDICATIONS & USAGE SECTION

Chronic wounds, surgical wounds, Donor sites/grafts, Diabetic ulcers, chronic ulcers of mixed vascular etiologies, venous stasis ulcers, Pressure ulcers (stages I-IV), partial & full thickness wounds, donor sites/grafts.

DIRECTIONS FOR USE

DOSAGE & ADMINISTRATION SECTION

(NOTE: ALWAYS HANDLE USING ASEPTIC TECHNIQUE)

WOUND BED PREPARATION & APPLICATIONDRESSING CHANGES & REAPPLICATIONS
  • 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.
  • Remove the tip cap from the 3cc syringe.
  • Attach the flexible injector tip securely to the syringe.
  • 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.
  • After application, use an appropriate non-adherent occlusive dressing. Change dressing as necessary.
  • Frequency of dressing changes typically occur every 2-5 days, or as determined by the healthcare provider.
  • Once wound is cleansed using proper technique Keroxx® Flowable Wound Matrix may be reapplied.
  • Proceed with reapplication of appropriate non-adherent occlusive secondary dressing.
  • 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.

PRINCIPAL DISPLAY PANEL - 3 cc Syringe Box
PRINCIPAL DISPLAY PANEL - 3 cc Syringe Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71474-304-03keroxx7.5 g in 1 SYRINGEGEL7.51
71474-304-03keroxx1 in 1 BOXGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71474-304KEROXX (AMINO ACIDS, HAIR KERATIN) GEL [MOLECULAR BIOLOGICALS, LLC]12 package rows20181201_584f247b-1a6d-4082-82e8-a17d8015ff1b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71474-30471474-304-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMINO ACIDS, HAIR KERATING46579QK1MACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.