KERASORB- amino acids, hair keratin

kerasorb by

Drug Labeling and Warnings

kerasorb 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

Foam Wound Matrix

Rx Prescription Only - Single Use

• STERILE: R

C E
0 1 2 3

CAUTION

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician (or properly licensed Healthcare practitioner).

DESCRIPTION

Kerasorb® is an advanced bilayer wound care device designed for medium to highly exudative wounds. It is comprised of an absorbent foam with a Keratin (Replicine) wound matrix layer designed for wounds with medium to high exudate. Kerasorb foam wound matrix provides a scaffold for cellular migration, proliferation and capillary growth, while permitting drainage of excess fluids that may accumulate onto the wound bed. It is supplied in single use keratin foam matrix.

INDICATIONS FOR USE

Medium to High exudative wounds: Chronic wounds, surgical wounds, Donor sites/grafts, Diabetic ulcers, chronic ulcers of mixed vascular etiologies, venous stasis ulcers, Pressure ulcers (stages I-IV), partial & full thickness wounds, donor sites/grafts with medium to high exudate.

DOSAGE & ADMINISTRATION

DIRECTIONS FOR USE      (NOTE: ALWAYS HANDLE USING ASEPTIC TECHNIQUE)

WOUND BED PREPARATION & APPLICATION 1. Prepare wound area using standard debridement methods to ensure the wound is free of debris and devitalized tissue. The wound may be surgically debrided to ensure the wound edges contain viable tissue. A small influx of blood may be permitted into the wound. 2. Using sterile technique remove Kerasorb foam wound matrix from the pouch. 3. If necessary cut the Kerasorb foam wound matrix into a piece slightly larger than the outline of the wound area (approximately 1.5cm). 4. Apply Kerasorb® Foam Wound Matrix into the wound area. Ensure that the keratin matrix layer ("shiny side") makes contact with the wound bed. Secure in place using preferred method by healthcare provider(Steri-strips, sutures, tape). dressing.

5. After application use an appropriate occlusive; MATRIX CHANGES & REAPPLICATIONS 6. Change kerasorb foam wound matrix as necessary. Frequency of dressing changes typically occur every 5-7 days, or as determined by the healthcare provider. 7. Once wound is cleansed using proper technique Kerasorb® Foam Wound Matrix may be reapplied. 8. Proceed with reapplication of appropriate occlusive secondary dressing. 9. If clinical signs of infection, excessive redness, blistering or suspected allergic reaction occurs the Matrix material should not be reapplied and proper notification and documentation should be done.

CONTRADICATIONS

Kerasorb® Foam Wound Matrix should not be used in patients with known sensitivity to keratin. The device is not indicated for third degree burns.

PRECAUTIONS

Do not reuse or re-sterilize. Do not use if package is open or if package is unsealed. Use prior to expiration date.

STORAGE

Do not use if package has been opened or damaged. Should be stored at a clean, dry location at ambient temperature.

HOW SUPPLIED

Kerasorb® is supplied sterile, in single use pouch containing one foam wound matrix.

Kerasorb®	4cm × 4cm / unit	SKU/Model 71474-305-01
Kerasorb®	4cm × 4cm / [Box of 5] units	SKU/Model 71474-305-05

SPL UNCLASSIFIED SECTION

Manufactured for:
Molecular Biologicals, LLC
Pasadena, TX 77505 | 1-844-793-9933
By Keraplast Research, Ltd
Gerald St. Lincoln, 7674 NZ

Kerasorb® is a registered trademark of Molecular Biologicals, LLC.
The product incorporates patented and /or patent pending technologies owned by Molecular Biologicals, LLC.

Issue Date 01Jan17
DWG005/9

PRINCIPAL DISPLAY PANEL - 5 Package Box

kerasorb

5 x NDC: 71474-305-05
10 cm x 10 cm (4" x 4")

MOLECULAR
BIOLOGICALS
replicine™

LOT

DWG007/5

C E
0 1 2 3

STERILE R

i

⌄
0°C
32°F

35°C
95°F
⌃

Manufactured for: Molecular Biologicals, LLC
Pasadena, TX 77505
by
Keraplast Research, Ltd
Gerald St. Lincoln, 7674 NZ

INGREDIENTS AND APPEARANCE

KERASORB 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:71474-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M) (AMINO ACIDS, HAIR KERATIN - UNII:G46579QK1M)	AMINO ACIDS, HAIR KERATIN	100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71474-305-01	1 in 1 POUCH
1		1 in 1 PACKAGE; Type 0: Not a Combination Product
2	NHRIC:71474-305-05	5 in 1 BOX
2		5 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXEMPT DEVICE	FRO	12/11/2018

Labeler - Molecular Biologicals, LLC (079518915)