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Protyl Ag Wound Gel Prescribing Information

Package insert / product label
Generic name: hydrolyzed collagen, silver oxide
Dosage form: gel

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

Indications and Usage for Protyl Ag Wound Gel

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

Protyl Ag Wound Gel 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.

Protyl Ag Wound Gel Dosage and 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.

Precautions

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 is Protyl Ag Wound Gel 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.

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)

PRINCIPAL DISPLAY PANEL - 42 g Tube Carton
PROTYL AG
dressing, wound, drug gel
Product Information
Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:71740-010
Route of AdministrationTOPICAL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:71740-010-421 in 1 CARTON
142 g in 1 TUBE; 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 NOTIFICATIONK06122703/13/201905/31/2022
Labeler - Avondale Pharmaceuticals, LLC (080843532)