LuraDRox Rx Wound Gel by Alvix Laboratories LuraDrox Rx Wound Gel

LuraDRox Rx Wound Gel by

Drug Labeling and Warnings

LuraDRox Rx Wound Gel by is a Other medication manufactured, distributed, or labeled by Alvix Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LURADROX RX WOUND GEL- dressing, wound, drug    
Alvix Laboratories

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LuraDrox Rx Wound Gel

DESCRIPTION

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

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

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

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

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

HOW SUPPLIED

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

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

LuraDrox Rx Wound Gel Primary Label

LURADROX RX WOUND GEL 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:15455-9569

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:15455-9569-1	5 mL in 1 PACKET; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K162017	03/27/2019	12/11/2019

Labeler - Alvix Laboratories (962445925)

Revised: 12/2019

Document Id: fb0d2f88-8c9c-4f62-a756-05b6a7ae8a2d

69404-2

Set id: 2ca0a7b8-cdfa-49b9-9f3b-44379c5042c6

Version: 2

Effective Time: 20191211

 

Alvix Laboratories