KERAGEL- dressing, wound, drug  
MOLECULAR BIOLOGICALS, LLC

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keragel®
Wound Gel

STERILER

C E
0 1 2 3

Rx Only
Single Use
For Topical Dermatological use only.

Description

keragel® is a keratin enriched gel category dressing utilizing keratin technology to create and maintain a moist wound environment. It is presented sterile in a tube for ease of application.

INDICATIONS FOR USE

keragel® is designed for acute/chronic superficial and partial thickness wounds with dry to medium exudate, such as:

ATTENTION

If the wound is infected, it is advised that you consult with your physician or health care professional.

DIRECTIONS FOR USE

  1. Cleanse and debride the wound in accordance with normal procedures.
  2. Ensure that the skin surrounding the wound is dry.
  3. The tube is opened using the piercer cap to break the nozzle seal. To ensure sterility, sanitise the piercer cap before using.
  4. Apply a 3mm to 6mm (1/8inch to 1/4inch) layer of keragel® to cover the entire wound surface.
  5. Cover with an appropriate secondary dressing if needed.

RECOMMENDED CARE

The wound should be inspected daily or as indicated by a physician. For wounds that appear dry more gel should be applied to the area. Wounds should be cleansed regularly and new gel applied.

INGREDIENTS

Keratin, phenoxyethanol, hydroxyethylcellulose, glycerol, sorbitol, propylene glycol, lactic acid.

HOW SUPPLIED

keragel® 20gm individual tube:NDC 71474-301-20
keragel 5 gm individual tube:NDC 71474-301-05

STORAGE / PRECAUTIONS

keragel® should be stored in dry conditions between 0° and 35°C (32° and 95° F).

Do not use if the tube has been damaged prior to use. Sterility is guaranteed until the tube is first opened. Do not re-sterilise.

CAUTION: RX ONLY. Federal law restricts this device to sale by or on the order of a physician.

Manufactured for: Molecular Biologicals, LLC
Pasadena, TX 77505 | 1-844-793-9933

ECREP

Keraplast Research Limited, Gerald St., Lincoln 7674, NZ
Medical Device Consultancy, 7 Pinewood Drive, Ashley Heath,
Market Drayton, Shropshire TF9 4PA, United Kingdom

keragelT® is a registered trademark of
Keraplast Technologies LLC.
The product incorporates patented and/or patent pending
technologies owned by Keraplast Technologies LLC.

Issue Date 8/2017
DWG106/1

PRINCIPAL DISPLAY PANEL - 5 g Tube Box

For Wounds & Burns

Keragel®
Enriched With Bioactive Keratin

1x 1 Tube
NDC 71474-301-05
5g/0.2oz
Rx Only

SAMPLE - NOT FOR SALE

PRINCIPAL DISPLAY PANEL - 5 g Tube Box
KERAGEL 
dressing, wound, drug
Product Information
Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:71474-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin100 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:71474-301-201 in 1 BOX
120 g in 1 TUBE; Type 0: Not a Combination Product
2NHRIC:71474-301-1010 in 1 BOX
220 g in 1 TUBE; Type 0: Not a Combination Product
3NHRIC:71474-301-3030 in 1 BOX
320 g in 1 TUBE; Type 0: Not a Combination Product
4NHRIC:71474-301-555 in 1 BOX
420 g in 1 TUBE; Type 0: Not a Combination Product
5NHRIC:71474-301-051 in 1 BOX
55 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EXEMPT DEVICEFRO02/11/2009
Labeler - MOLECULAR BIOLOGICALS, LLC (079518915)

Revised: 9/2018
Document Id: a2a932e8-7084-48a8-aed1-39077582963d
Set id: fabf8227-31c7-4347-9755-1cd7fc62c8a1
Version: 6
Effective Time: 20180926
 
MOLECULAR BIOLOGICALS, LLC