Label: KEROXX- amino acids, hair keratin gel

  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated November 30, 2018

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  • SPL UNCLASSIFIED SECTION

    Flowable Wound Matrix

    Rx Prescription Only
    Single Use
    Topical use Only

    STERILER

    C E
    0 1 2 3

  • CAUTION

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

  • DESCRIPTION

    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

    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

    (NOTE: ALWAYS HANDLE USING ASEPTIC TECHNIQUE)

    WOUND BED PREPARATION & APPLICATIONDRESSING 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 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

    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

    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

    Do not use if Package has been opened or damaged. Should be stored at a clean, dry location at ambient temperature.

  • HOW SUPPLIED

    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

    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
  • INGREDIENTS AND APPEARANCE
    KEROXX 
    dressing, wound, drug gel
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:71474-304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M) (AMINO ACIDS, HAIR KERATIN - UNII:G46579QK1M) AMINO ACIDS, HAIR KERATIN100 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71474-304-031 in 1 BOX
    17.5 g in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXEMPT DEVICEFRO02/11/2017
    Labeler - Molecular Biologicals, LLC (079518915)
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