Label: AZADROX RX WOUND GEL-

  • NDC Code(s): 00315455957015, 00315455957039
  • Packager: Alvix Laboratories, LLC
  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 18, 2020

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    AzaDrox™ Rx Wound Gel is a wound dressing hydrogel that helps maintain a moist wound environment that is conducive to healing by either absorbing or donating moisture and wound exudates.

  • INDICATIONS FOR USE

    AzaDrox™ Rx Wound Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.

  • PRECAUTIONS

    1. Always use AzaDrox™ Rx Wound Gel exactly as indicated by the prescribing physician. Consult with a healthcare professional if you have any concerns or questions about the wound.

    2. Always be alert for signs of wound infection or worsening conditions. These can include:

    • Pus or cloudy fluid draining from the wound
    • Increased redness around the wound
    • Wound has become extremely tender
    • Increased pain or swelling 48 hours after wound occurred
    • Onset of fever

    3. The gel is designed for use on any part of the body except for oral and opthalmic use. Do not use the gel in any other manner.

  • HOW TO APPLY

    Home use of AzaDrox™ Rx Wound Gel should only be allowed if indicated by the prescribing physician. Always use AzaDrox™ Rx Wound Gel exactly as indicated by the prescribing physician.


    1. Wash your hands with soap and water before touching the wound.

    2. Carefully clean the wound using soap and water, or as otherwise indicated by the prescribing physician.

    3. Dispense gel onto appropriate clean applicator (such as a tongue depressor or gauze) in a sufficient amount to liberally cover the wound. Cover the gel if desired with a secondary cover such as a gauze dressing wrap, film, or non-woven adhesive secondary dressing.

    4. Remove product from the skin within 24 hours by leaning the wound site with soap and water.

    5. Discard remaining product.

  • INGREDIENTS

    Deionized water, carbopol, silver as nanoparticles, urea (less than 1%), sodium hydroxide

  • HOW SUPPLIED

    AzaDrox™  Rx Wound Gel is supplied in a carton containing 20 single-use 5 mL sachets. 1545595703 (GTIN: 00315455957039)

  • PRESCRIPTION MEDICAL DEVICE: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

    STORE AT ROOM TEMPERATURE

    Keep this and other similar products out of the reach of children.

    Alvix Laboratories, LLC

    Ocean Springs, MS 39564

    1 888 526 5449

  • AzaDrox™ Rx Wound Gel Package Insert

    AzaDrox PI

  • AzaDrox™ Rx Wound Gel Primary Label

    AzaDrox Carton

  • INGREDIENTS AND APPEARANCE
    AZADROX RX WOUND GEL 
    dressing, wound, drug
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)GS1:00315455957039
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1GS1:003154559570155 in 1 PACKET
    1GS1:00315455957039100 mL in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK16201705/18/2020
    Labeler - Alvix Laboratories, LLC (962445925)