Label: KERAGELT- glycerin

  • NHRIC Code(s): 71474-302-20, 71474-302-10, 71474-302-30, 71474-302-05, view more
    71474-302-11, 71474-302-28, 71474-302-55, 71474-302-54
  • Packager: MOLECULAR BIOLOGICALS, LLC
  • Category: PRESCRIPTION MEDICAL DEVICE LABEL

Drug Label Information

Updated October 8, 2018

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  • SPL UNCLASSIFIED SECTION

    Rx Only
    Single Use
    For Topical Dermatological use only.

    STERILER

    C E
    0 1 2 3

  • Description

    keragelT® is a keratin enriched gel category dressing utilizing keratin technology to create and maintain a moist wound environment. It is presented sterile in a tube for ease of application.

  • INDICATIONS FOR USE

    keragelT® is designed for acute/chronic superficial and partial thickness wounds with dry to medium exudate, such as:

    • Venous leg ulcers
    • Arterial ulcers
    • Diabetic foot ulcers
    • Pressure ulcers
    • Skin graft donor sites
    • Sunburns
    • First and Second Degree burns
  • ATTENTION

    If the wound is infected, it is advised that you consult with your physician or health care professional.

  • DIRECTIONS FOR USE

    1. Cleanse and debride the wound in accordance with normal procedures.
    2. Ensure that the skin surrounding the wound is dry.
    3. The tube is opened using the piercer cap to break the nozzle seal.
      To ensure sterility, sanitise the piercer cap before using.
    4. Apply a 3mm to 6mm (1/8inch to 1/4inch) layer of keragelT® to cover the entire wound surface daily or three times a day as indicated by a healthcare professional.
    5. Cover with an appropriate secondary dressing if needed.
  • RECOMMENDED CARE

    The wound should be inspected daily or as indicated by a physician. For wounds that appear dry more gel should be applied to the area.

  • INGREDIENTS

    Keratin, phenoxyethanol, hydroxyethylcellulose, glycerol, sorbitol, propylene glycol, lactic acid.

  • HOW SUPPLIED

    keragelT® 20gm individual tube:NDC 71474-302-20
    keragelT® 5gm individual tube:NDC 71474-302-05

    STORAGE / PRECAUTIONS

    keragelT® should be stored in dry conditions between 0° and 35°C (32° and 95° F).

    Do not use if the tube has been damaged prior to use.

    Sterility is guaranteed until the tube is first opened.

    Do not re-sterilise.

    CAUTION: RX ONLY. Federal law restricts this device to sale by or on the order of a physician.

  • SPL UNCLASSIFIED SECTION

    Manufactured for: Molecular Biologicals, LLC
    Pasadena, TX 77505 | 1-844-793-9933

    ECREP

    Keraplast Research Limited, Gerald St., Lincoln 7674, NZ
    Medical Device Consultancy, 7 Pinewood Drive, Ashley Heath,
    Market Drayton, Shropshire TF9 4PA, United Kingdom

    keragelT® is a registered trademark of
    Keraplast Technologies LLC.
    The product incorporates patented and/or patent pending
    technologies owned by Keraplast Technologies LLC.

    Issue Date 9/2017
    DWG107/1

  • PRINCIPAL DISPLAY PANEL - 20 g Tube Box

    keragelT®

    10 x
    NDC 71474-302-10
    20g/0.7oz

    Rx Only

    MOLECULAR
    BIOLOGICALS

    replicine™

    PRINCIPAL DISPLAY PANEL - 20 g Tube Box
  • INGREDIENTS AND APPEARANCE
    KERAGELT 
    dressing, wound, drug
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:71474-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin100 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71474-302-201 in 1 BOX
    120 g in 1 TUBE; Type 0: Not a Combination Product
    2NHRIC:71474-302-1010 in 1 BOX
    220 g in 1 TUBE; Type 0: Not a Combination Product
    3NHRIC:71474-302-3030 in 1 BOX
    320 g in 1 TUBE; Type 0: Not a Combination Product
    4NHRIC:71474-302-051 in 1 BOX
    45 g in 1 TUBE; Type 0: Not a Combination Product
    5NHRIC:71474-302-1110 in 1 BOX
    55 g in 1 TUBE; Type 0: Not a Combination Product
    6NHRIC:71474-302-2828 in 1 BOX
    65 g in 1 TUBE; Type 0: Not a Combination Product
    7NHRIC:71474-302-555 in 1 BOX
    720 g in 1 TUBE; Type 0: Not a Combination Product
    8NHRIC:71474-302-545 in 1 BOX
    85 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXEMPT DEVICEFRO02/11/2009
    Labeler - MOLECULAR BIOLOGICALS, LLC (079518915)
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