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Hylase Wound Gel

Generic Name: sodium hyaluronate
Dosage Form: gel

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Hylase Wound Gel

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 naturallyoccuring 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:  Hylase Wound Gel is suitable for exuding wounds 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:
  • Hylase Wound Gel is for external use only.
  • If signs of infection become present, consult a physician
  • Keep this and all medications out of the reach of children.
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 profefessional.  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 areas.  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 covery 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 foil 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 freeze 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

The packaging below represents the current tube labeling used.

Principal display panel for 75 g tubing:

75g         NDC 0095-0073-75

HYLASE®                    Rx
Wound Gel               Only


FOR EXTERNAL USE ONLY

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

Manufactured for:  ECR          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).

Usual 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


HYLASE WOUND  
sodium hyaluronate gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0095-0073
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hyaluronate Sodium (Hyaluronic Acid) Hyaluronate Sodium 2.5 g  in 100 g
Packaging
# Item Code Package Description
1 NDC:0095-0073-75 1 TUBE (TUBE) in 1 CARTON
1 75 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/06/2012
Labeler - ECR Pharmaceuticals Co., Inc. (831116350)
Registrant - Great Southern Laboratories (056139553)
Establishment
Name Address ID/FEI Operations
Great Southern Laboratories 056139553 manufacture
Revised: 01/2012
 
ECR Pharmaceuticals Co., Inc.



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