FDA.reportPublic FDA data

Korium

Manufacturer
GR8BIO LLC | Homeocare Laboratories Inc.
Effective date
2020-01-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:12:10

Label at a glance#

ProductKorium Wound care
Active ingredientCALENDULA OFFICINALIS WHOLE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis 1X HPUS -2%

OTC - PURPOSE SECTION

Healing Agent

INDICATIONS & USAGE SECTION

May help promote healing of minor cuts, scratches and chafing.

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

DO NOT USE if you are allergic to Calendula officinalis or to any of this product's inactive ingredients.

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT:

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

You may experience some transient mild pain on the wound area.

OTC - STOP USE SECTION

STOP USE AND ASK DOCTOR IF YOU:

Have any allergic reaction to this product.

Experience a deep or puncture wound, animal bite, or serious burn.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KWEEP OUT OF REACH OF CHILDREN. If swallowed get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • clean affected area thoroughly before applying
  • apply spray twice a day (every 12 hours) on affected area until entirely covered.
  • let dry and cover with a sterile bandage to promote healing.
  • continue use as needed

OTHER SAFETY INFORMATION

OTHER INFORMATION

Store at room temperature 68-77°F (20-25°C).

Do not use if tamper evident seal is broken.

INACTIVE INGREDIENT SECTION

Butylated Hydroxytoluene

Ethanol

Polyethylene Glycol

Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70811-001-002022-01-28C16284748780-1d6a99b39-6ceb-a426-e053-dadaa90af4c2Korium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70811-001-00KoriumWound care20 mL in 1 BOTTLE, SPRAYSPRAY202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70811-001KORIUM WOUND CARE (CALENDULA OFFICINALIS 1X HPUS) SPRAY [GR8BIO LLC]2Legacy NDC, 1 package rows20200125_441eb19f-4280-01b7-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70811-00170811-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CALENDULA OFFICINALIS WHOLEPFR03EBU0HACTIB
ALCOHOL3K9958V90MIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
441eb19f-4281-01b7-e054-00144ff8d46c441eb19f-4280-01b7-e054-00144ff8d46c2016-12-20WarningsExact identifier
spl set id: 441eb19f-4280-01b7-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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