Protyl Ag by Avondale Pharmaceuticals, LLC PROTYL AG- gel

Protyl Ag by

Drug Labeling and Warnings

Protyl Ag by is a Other medication manufactured, distributed, or labeled by Avondale Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

(hyCURE® is a unique Type 1 Bovine Hydrolyzed Collagen; 1% Silver Oxide)

Indications

For prescription use only. Protyl Ag is indicated for the treatment of partial and full thickness wounds, including;

• pressure injuries(Stages 1-4) diabetic ulcers grafted wounds and donor sites surgical wounds superficial wounds:
  • venous stasis ulcers
  • first and second degree burns
  • traumatic wounds
  • ulcers resulting from arterial insufficiency

Description

Protyl Ag is an absorbent hydrolyzed collagen gel for the management of exudative wounds. It provides a physiologically favorable moist wound environment for wound healing.

Protyl Ag absorbs excess wound exudate. Protyl Ag is made from natural materials that contain the proteins and amino acids that constitute the major building blocks of normal skin and connective tissue as well as silver as a preservative to control bacterial growth within the gel.

Protyl Ag provides a physiologically favorable environment that encourages wound healing and conforms to the wound site. It is easy to use, biocompatible and biodegradable. Protyl Ag supports natural autolysis by rehydrating and softening necrotic tissue and eschar thereby encouraging autolytic debridement. The silver preservative in the dressing controls microbial growth within the gel.

Product Administration

• Cleanse the wound site using normal saline or sterile water.
• Apply a layer of gel directly into the wound site and onto the surrounding area.
• Cover the wound with a non-adherent dressing.
• Reapply gel and redress as needed. Superficial wounds such as cuts and abrasions may not require a secondary dressing due to the film that the gel forms on the wound site after drying.
• Dressing may be moistened with sterile water or normal saline to ease removal.

Caution

In case of deep or puncture wounds or serious burns, consult a physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult a physician.

Contraindications

Contraindicated for individuals with a known sensitivity to silver.

How Supplied

Protyl Ag Rx Wound Gel is available in a 42g tube, NDC: 71740-010-42.

Storage

Store at room temperature (59˚F - 86˚F) and protect from freezing.

Extreme temperatures may affect viscosity, but will not affect performance of the product.

SPL UNCLASSIFIED SECTION

Manufactured for:
Avondale Pharmaceuticals, LLC, Birmingham, AL
Questions: Avondale Pharmaceuticals, LLC
Call: 1-800-528-3058 or
Email: CustomerService@AvondalePharm.com

hyCURE is a registered trademark of The Hymed Group Corporation
Protyl Ag is a trademark of Avondale Pharmaceuticals, LLC

122964

PRINCIPAL DISPLAY PANEL - 42 g Tube Carton

NDC: 71740-010-42
Rx Only

Protyl Ag™ Rx Wound Gel
(hyCURE® is a unique Type 1 Bovine Hydrolyzed Collagen; 1% Silver Oxide)

AVONDALE
PHARMACEUTICALS

Net Wt 1.5 oz (42 g)

INGREDIENTS AND APPEARANCE

PROTYL AG 
dressing, wound, drug gel

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:71740-010
Route of Administration	TOPICAL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71740-010-42	1 in 1 CARTON
1		42 g in 1 TUBE; 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	K061227	03/13/2019

Labeler - Avondale Pharmaceuticals, LLC (080843532)