Hylase Wound Gel

HYLASE WOUND GEL - hyaluronate sodium, hydroxyethyl cellulose (140 mpa.s at 5%), methylparaben, polyethylene glycols and water  
ECR Pharmaceuticals Co., Inc.

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Hylase Wound Gel RX Only

NDC 0095-0073-75

For External Use Only

Description: Hylase Wound Gel is formulated to provide wound care dressing and management.

Hylase Wound Gel is a combination of emollients and sodium hyaluronate which function to maintain tissue hydration and support the healing process. Hylase Wound Gel has been demonstrated to be of value in the management of certain skin ulcers and wounds. Sodium hyaluronate is a salt of hyaluronic acid, a naturallly occuring molecule found in various body tissues. The sodium hyaluronate present in Hylase Wound Gel is synthetically derived.

Ingredients: Sodium Hyaluronate (2.5%), Hydroxyethylcellulose, Methylparaben, Polyethylene Glycol, Water.

Indications and Usage: Hylae Wound Gel is suitable for exuding wound such as leg ulcers, pressure ulcers, diabetic ulcers, for the management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, and to aid in the healing of minor abrasions and cuts.

Contraindications: Hylase Wound Gel is contraindicated in persons with a known hypersensitivity to any of the ingredients in the formulation.

Warnings: Prolonged use of the product may give rise to sensitization phenomena. Should this occur, the patient should discontinue use of the product immediately and consult a physician.

Precautions and Observations:

Supportive Care:

Appropriate supportive measures should be taken where indicated, e.g. the use of graduated compression bandaging in the management of venous leg ulcers, or pressure relief measures in the management of pressure ulcers. The control of blood glucose as well as appropriate advice regarding pressure relief measures should be provided to patients with diabetic foot ulcers. Colonization of chronic wounds is common and the use of Hylase Wound Gel is not contraindicated. Hylase Wound Gel may be used on infected wounds under medical supervision and in conjunction with other appropriate therapy and frequent monitoring of the wound by the healthcare professional.

Instructions for Use: Hylase Wound Gel should be applied after the ulcer or wound is cleaned with normal saline solution. Other cleaning agents are not recommended. Debridement (surgical cleaning) of the ulcer or wound may be performed at the discretion of the healthcare professional. Excess moisture should be removed using dry gauze. Hylase Wound Gel is applied liberally into the cavity of the ulcer or wound and to the surrounding area. After applying Hylase Wound Gel, a non-stick gauze dressing (Telfa pad or other suitable non-stick pad) should be placed on the wound site. A gauze dressing should always be placed on the wound after applying Hylase Wound Gel. A self-adhesive bandage or suitable tape adhesive should be wrapped over the non-stick gauze dressing. The entire process of wound cleaning, applying Hylase Wound Gel, the application of a suitable covering and the bandaging of the area should be repeated daily.

How Supplied: Hylase Wound Gel is available in a 75 gram tube with tamper evident seal (NDC 0095-0073-75) and a 10 gram Physician sample (NDC 0095-0073-09). Do not use if tamper evident foil seal is broken or missing. Lot number and expiry date are located on the crimped end of tube.

Storage: Store at room temperature, 15° - 30°C (59°- 86°F) in a dry place. Do not freezed or expose to temperatures above 35°C (95°F).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Hylase Wound Gel covered by Patent Nos, 5,897,880, 6,063,405, 6,120,804, and 6,335,035.

Manufactured for:

ECR Pharmaceuticals Co., Inc.

Richmond, Virginia 23255

Manufactured by:

Great Southern Laboratories

Houston, Texas 77099

ML 0073

Rev. 11/2011

Product Packaging

Principal display panel for Hylase Wound Gel 75 g label.

75 g NDC 0095-0073-75

HYLASE

Wound Gel

Rx Only

FOR EXTERNAL USE ONLY

Contents: Sodium Hyaluronate (2.5%), Hydroxyethylcellulose, Methylparaben,

Polyethylene Glycol, Water.

Manufactured for: ECR logo

ECR Pharmaceuticals Co., Inc.

Richmond, VA 23255

Storage: Store at 15°-30°C (59°-86°F) in a dry place. Do not freeze or expose to

temperatures above 35°C (95°F).

Ususal Application: Once daily with appropriate cleaning and dressing of wound.

See accompanying package insert for details. Do not use if tamper

evident foil seal is broken or missing.

Lot number and expiry date are located on crimped end of tube.

Hylase Wound Gel covered by Patent Nos,

5,897,880 6,063,405 6,120,804 6,335,035

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

ML 0073 Rev 05/2011

Product Packaging

Established Pharmacological Class
SubstancePharmacological Class
Hylase Wound GelDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

HYLASE WOUND GEL 
Product Information
Product TypeItem Code (Source)NHRIC:0095-0073
Product Characteristics
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NHRIC:0095-0073-7575 g in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK02032501/06/201211/21/2012

Labeler - ECR Pharmaceuticals Co., Inc. (831116350)

Revised: 11/2012 ECR Pharmaceuticals Co., Inc.