FDA.reportPublic FDA data

keragel ® Wound Gel

Manufacturer
MOLECULAR BIOLOGICALS, LLC
Effective date
2018-09-26
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:49:08

Label at a glance#

Productkeragel
Active ingredientGlycerin
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

STERILER

C E
0 1 2 3

Rx Only
Single Use
For Topical Dermatological use only.

Description

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

keragel® 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

SPL UNCLASSIFIED SECTION

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

DIRECTIONS FOR USE

DOSAGE & ADMINISTRATION SECTION

  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.

INGREDIENTS

SPL UNCLASSIFIED SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

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

STORAGE / PRECAUTIONS

STORAGE AND HANDLING SECTION

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.

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 5 g Tube Box

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71474-301-05keragel5 g in 1 TUBE56
71474-301-05keragel1 in 1 BOX16
71474-301-10keragel20 g in 1 TUBE206
71474-301-10keragel10 in 1 BOX106
71474-301-20keragel1 in 1 BOX16
71474-301-20keragel20 g in 1 TUBE206
71474-301-30keragel20 g in 1 TUBE206
71474-301-30keragel30 in 1 BOX306
71474-301-55keragel5 in 1 BOX56
71474-301-55keragel20 g in 1 TUBE206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71474-301KERAGEL (GLYCERIN) [MOLECULAR BIOLOGICALS, LLC]610 package rows20181010_fabf8227-31c7-4347-9755-1cd7fc62c8a1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71474-301-05GM - Gram71474-301ef510378-67fc-4f96-a667-262a03d214bc12021-12-08
71474-301-10GM - Gram71474-3014b5fb54d-8433-4753-8014-93fd4f5a081d12017-08-11
71474-301-20GM - Gram71474-301aac6587d-5438-4c87-8a7a-088ac89a252212017-08-11
71474-301-30GM - Gram71474-301dc37793f-0ec7-49d8-baf4-0bf2ad61a46512017-08-11
71474-301-55GM - Gram71474-30119b328a8-e99c-411c-ba95-8709c3ede32912017-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71474-30171474-301-20, 71474-301-10, 71474-301-30, 71474-301-55, 71474-301-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
GlycerinPDC6A3C0OXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 8 · 159 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsName fallback
generic name: GLYCERIN
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsName fallback
generic name: GLYCERIN
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsName fallback
generic name: GLYCERIN
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsName fallback
generic name: GLYCERIN
Growth TreatmentGLYCERINShantou Ouhoe Technology Co., Ltd.59fe12eb-574f-a199-e063-6394a90abd062026-08-26WarningsName fallback
generic name: GLYCERIN
SWRDHJ Hair Growth SerumGLYCERINGuangzhou Houkea Biotechnology Co., Ltd.59da3063-66bd-31d2-e063-6294a90abab52026-08-25WarningsName fallback
generic name: GLYCERIN
Izzch1219 Hair Growth FormGLYCERINGuangzhou Houkea Biotechnology Co., Ltd.59da92a8-17a4-b894-e063-6294a90a37ed2026-08-25WarningsName fallback
generic name: GLYCERIN
YIUI Hair Regrowth FoamGLYCERINGuangzhou Houkea Biotechnology Co., Ltd.59d7399e-aeb1-824b-e063-6394a90aebe82026-08-24WarningsName fallback
generic name: GLYCERIN
Nail Renewal LiquidGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.581f7192-fc17-a706-e063-6394a90a3ffa2026-08-11WarningsName fallback
generic name: GLYCERIN
Intertrigo Relief CreamGLYCERINShantou South Moon Biotechnology Co., Ltd.587220c9-0ae9-3438-e063-6394a90a0a862026-08-07WarningsName fallback
generic name: GLYCERIN
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsName fallback
generic name: GLYCERIN
HOUKEA Bee Venom Skin Restoration CreamGLYCERINGuangzhou Houkea Biotechnology Co., Ltd.57a8a8e9-7f18-ad01-e063-6394a90a1eac2026-07-29WarningsName fallback
generic name: GLYCERIN
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsName fallback
generic name: GLYCERIN
SOHEJU Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.560089ff-3361-90b7-e063-6294a90ada422026-07-09WarningsName fallback
generic name: GLYCERIN
Bee Venom Psoriasis Wart Caring CreamGLYCERINShantou Ximonth Biotechnology Co., Ltd.563a423c-e9dd-1cab-e063-6294a90a8c6a2026-07-09WarningsName fallback
generic name: GLYCERIN
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsName fallback
generic name: GLYCERIN
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsName fallback
generic name: GLYCERIN
EELHOE Sleep Aid PatchGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.550b0494-ca6d-c897-e063-6394a90a87512026-06-24WarningsName fallback
generic name: GLYCERIN
Hair Regrowth LiquidGLYCERINShantou Woodsleep Biotechnology Co., Ltd.54e662e7-9c63-ad6b-e063-6294a90a1b8d2026-06-23WarningsName fallback
generic name: GLYCERIN
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsName fallback
generic name: GLYCERIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.