FDA.reportPublic FDA data

IODINE

Manufacturer
Borisovskiy Zavod Medicinskikh Preparatov JSC
Effective date
2015-11-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:13

Label at a glance#

ProductIODINE
Active ingredientIODINE, POTASSIUM IODIDE
Label structure9 sections

Indications and uses

For inflammatory and infectious diseases of skin, cuts, minor injuries, wounds, myositis, neuraldia; for disinfection of the operational field.

Dosage and administration

Apply to affected areas as needed or as directed by physician.

Storage and handling

Keep in a dark place at temperature below 25 o C.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Iodine - 0.5 g, Potassium Iodide - 0.2 g

Purpose

OTC - PURPOSE SECTION

Bactericidial - antiseptic

Uses

INDICATIONS & USAGE SECTION

For inflammatory and infectious diseases of skin, cuts, minor injuries, wounds, myositis, neuraldia; for disinfection of the operational field.

Warnings

WARNINGS SECTION

For external use only.

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

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected areas as needed or as directed by physician.

Other information

STORAGE AND HANDLING SECTION

Keep in a dark place at temperature below 25 oC.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethanol, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of vial labelimage of vial labelimage of group label 1image of group label 1image of group label 2image of group label 2

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
16638-166-382020-01-31C16284748780-19d75b9cf-cfe0-f424-e053-dadaa90a57ceDrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16638-166-38IODINE10 mL in 1 VIALSOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16638-166IODINE (IODINE ALCOHOLIC) SOLUTION [BORISOVSKIY ZAVOD MEDICINSKIKH PREPARATOV JSC]2Legacy NDC, 1 package rows20151126_dd1996bf-d7b4-4737-97fa-d98dda09e5c6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IODINEACTIVE INGREDIENT9679TC07X42
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9J2
IODIDE IONACTIVE MOIETY09G4I6V86Q2
IODINEACTIVE MOIETY9679TC07X42
ETHANOL, 2-(BIS(2-METHYLPROPYL)PHENOXY)-INACTIVE INGREDIENTAUK0O5KW1Y2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16638-16616638-166-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHANOL, 2-(BIS(2-METHYLPROPYL)PHENOXY)-AUK0O5KW1YIACT
WATER059QF0KO0RIACT
IODINE9679TC07X4ACTIB
POTASSIUM IODIDE1C4QK22F9JACTIM

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
256e7111-d07a-576e-e054-00144ff88e88dd1996bf-d7b4-4737-97fa-d98dda09e5c62015-11-26WarningsExact identifier
spl id: 256e7111-d07a-576e-e054-00144ff88e88
spl set id: dd1996bf-d7b4-4737-97fa-d98dda09e5c6

Reported adverse events (FAERS/openFDA)#

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