FDA.reportPublic FDA data

COLLOIDAL IODINEINJECTION

Manufacturer
JCI INSTITUTE OF MEDICAL SCIENCE
Effective date
2019-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:26

Label at a glance#

ProductCOLLOIDAL IODINEINJECTION
Active ingredientIODINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

iodine

INACTIVE INGREDIENT SECTION

potassium iodide, hydrogen water

OTC - PURPOSE SECTION

disinfection effect

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

Consult a physician before use

WARNINGS SECTION

For subcutaneous use only

keep in a room temperature

keep out of the direct sunlight

DOSAGE & ADMINISTRATION SECTION

for subcutaneous use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69164-5001-12021-01-29C16284748780-1ba0f9c33-5b7d-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69164-5001-1COLLOIDAL IODINEINJECTION10 mL in 1 SYRINGESOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69164-5001COLLOIDAL IODINEINJECTION (IODINE) SOLUTION [JCI INSTITUTE OF MEDICAL SCIENCE]1Legacy NDC, 1 package rows20190916_92a31a63-51de-1fec-e053-2995a90abe74.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69164-500169164-5001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM IODIDE1C4QK22F9JIACT
WATER059QF0KO0RIACT
IODINE9679TC07X4ACTIB

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
92a312d0-8399-0a06-e053-2a95a90a989b92a31a63-51de-1fec-e053-2995a90abe742019-09-14WarningsExact identifier
spl id: 92a312d0-8399-0a06-e053-2a95a90a989b
spl set id: 92a31a63-51de-1fec-e053-2995a90abe74

Reported adverse events (FAERS/openFDA)#

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