FDA.reportPublic FDA data

COLLOIDAL IODINEINJECTION

Manufacturer
JCI Colloidal Iodine Laboratory Co., Ltd.
Effective date
2023-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:00

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69164-0001-1COLLOIDAL IODINEINJECTION50 mL in 1 BOTTLE, GLASSSOLUTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69164-0001COLLOIDAL IODINEINJECTION (IODINE) SOLUTION [JCI COLLOIDAL IODINE LABORATORY CO., LTD.]11 package rows20230519_fbf00a3a-e2c3-deb3-e053-6394a90abde7.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
69164-000169164-0001-1

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fbf008ae-7aeb-665b-e053-6394a90af63cfbf00a3a-e2c3-deb3-e053-6394a90abde72023-05-17WarningsExact identifier
spl id: fbf008ae-7aeb-665b-e053-6394a90af63c
spl set id: fbf00a3a-e2c3-deb3-e053-6394a90abde7