LuraDRox Rx Wound Gel

Manufacturer
Alvix Laboratories
Effective date
2019-03-27
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:28:45

Label at a glance#

ProductLuraDRox Rx Wound Gel
Label structure8 sections

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

LuraDroxᵀᴹ 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

INDICATIONS & USAGE SECTION

LuraDroxᵀᴹ 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

PRECAUTIONS SECTION

1. Always use LuraDroxᵀᴹ 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 the wound occurred
  • Onset of fever

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

HOW TO APPLY

INSTRUCTIONS FOR USE SECTION

Home use of LuraDroxᵀᴹ Rx Wound Gel should only be allowed if indicated by the prescribing physician. Always use LuraDroxᵀᴹ 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 directed by the prescribing physician.

3.  Dispense gel onto an 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 cleaning the wound site with soap and water.

5.  Discard remaining product.

INGREDIENTS

INACTIVE INGREDIENT SECTION

Deionized water, carbopol, silver as nanoparticles, sodium hyaluronate (0.1%), sodium hydroxide

HOW SUPPLIED

HOW SUPPLIED SECTION

LuraDroxᵀᴹ Rx Wound Gel is supplied in a 5 ML squeezable sachet. 15455-9569-01

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

SPL UNCLASSIFIED SECTION

STORE AT ROOM TEMPERATURE

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

Alvix Laboratories, LLC

6601 Sunplex Drive

Ocean Springs, MS 39564

1 888 526 5449

LuraDrox Rx Wound Gel Package Insert

SPL PATIENT PACKAGE INSERT SECTION

image descriptionimage description

LuraDrox Rx Wound Gel Primary Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15455-9569-1ML - Milliliter15455-95693613f2f7-c2e1-45dc-a36d-d9c4ff8968ba12019-04-11

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15455-956915455-9569-1

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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