keragelT by MOLECULAR BIOLOGICALS, LLC KERAGELT- glycerin

keragelT by

Drug Labeling and Warnings

keragelT by is a Other medication manufactured, distributed, or labeled by MOLECULAR BIOLOGICALS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only
Single Use
For Topical Dermatological use only.

• STERILE: R

C E
0 1 2 3

Description

keragelT® 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

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

• Venous leg ulcers
• Arterial ulcers
• Diabetic foot ulcers
• Pressure ulcers
• Skin graft donor sites
• Sunburns
• First and Second Degree burns

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 keragelT® to cover the entire wound surface daily or three times a day as indicated by a healthcare professional.
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.

INGREDIENTS

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

HOW SUPPLIED

• keragelT® 20gm individual tube: NDC: 71474-302-20
• keragelT® 5gm individual tube: NDC: 71474-302-05

STORAGE / PRECAUTIONS

keragelT® 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.

SPL UNCLASSIFIED SECTION

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

• EC: REP

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 9/2017
DWG107/1

PRINCIPAL DISPLAY PANEL - 20 g Tube Box

keragelT®

10 x
NDC: 71474-302-10
20g/0.7oz

Rx Only

MOLECULAR
BIOLOGICALS

replicine™

INGREDIENTS AND APPEARANCE

KERAGELT 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:71474-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	Glycerin	100 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71474-302-20	1 in 1 BOX
1		20 g in 1 TUBE; Type 0: Not a Combination Product
2	NHRIC:71474-302-10	10 in 1 BOX
2		20 g in 1 TUBE; Type 0: Not a Combination Product
3	NHRIC:71474-302-30	30 in 1 BOX
3		20 g in 1 TUBE; Type 0: Not a Combination Product
4	NHRIC:71474-302-05	1 in 1 BOX
4		5 g in 1 TUBE; Type 0: Not a Combination Product
5	NHRIC:71474-302-11	10 in 1 BOX
5		5 g in 1 TUBE; Type 0: Not a Combination Product
6	NHRIC:71474-302-28	28 in 1 BOX
6		5 g in 1 TUBE; Type 0: Not a Combination Product
7	NHRIC:71474-302-55	5 in 1 BOX
7		20 g in 1 TUBE; Type 0: Not a Combination Product
8	NHRIC:71474-302-54	5 in 1 BOX
8		5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXEMPT DEVICE	FRO	02/11/2009

Labeler - MOLECULAR BIOLOGICALS, LLC (079518915)