FDA.reportPublic FDA data

Colloidal Iodine Ophthalmic

Manufacturer
JCI INSTITUTE OF MEDICAL SCIENCE
Effective date
2018-05-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:30

Label at a glance#

ProductColloidal Iodine Ophthalmic
Active ingredientIODINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

sodium iodide


INACTIVE INGREDIENT SECTION

electrolytic-reduction water


OTC - PURPOSE SECTION

opthalmic disorders
intranasal lesion, intra-oral lesion
prevention of the diseases above mentioned


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children


INDICATIONS & USAGE SECTION

apply eyewash several times a day in case of ophthalmic disorders
adjust the mumber of times being applying the eye drop, depending on symptho
it is better to increase the number of times for the quick recovery
for the intranasal disease, it is recommended to apply the drops several times a day
for the intra-oral disease, keep the drop in the mouth or use as toothpaste



WARNINGS SECTION

there may occurs the case of irritability when applying eye drop or nasal drop
do not worry about it because it is caused by the reaction of Iodine
But is it possibly think of the susceptibility to Iodine, which seldom occurs.
in case of irritability or rash, stop the use immediately and discuss with doctors
keep out of the direct sunlight


DOSAGE & ADMINISTRATION SECTION

ophthalmic and intranasal use


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package insert
package insert

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
69164-3001-12020-01-31C16284748780-19d75b9d1-00ea-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69164-3001-1Colloidal Iodine Ophthalmic30 mL in 1 BOTTLE, PLASTICSOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69164-3001COLLOIDAL IODINE OPHTHALMIC (IODINE) SOLUTION [JCI INSTITUTE OF MEDICAL SCIENCE]2Legacy NDC, 1 package rows20180512_7a7454fa-425f-4afb-8601-e31cc17f7dbb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IODINEACTIVE INGREDIENT9679TC07X41
IODINEACTIVE MOIETY9679TC07X41
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69164-300169164-3001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
6bf844a0-cfdf-b993-e053-2991aa0aca767a7454fa-425f-4afb-8601-e31cc17f7dbb2018-05-11WarningsExact identifier
spl id: 6bf844a0-cfdf-b993-e053-2991aa0aca76
spl set id: 7a7454fa-425f-4afb-8601-e31cc17f7dbb

Reported adverse events (FAERS/openFDA)#

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