FDA.reportPublic FDA data

Iodine

Manufacturer
Nice-Pak Products, LLC | Pharma Nobis, LLC
Effective date
2026-03-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:50:09

Label at a glance#

ProductIodine
Active ingredientIODINE
Label structure13 sections

Dosage and administration

clean the affected area apply a small amount on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Iodine tincture U.S.P. 100%

(2% Iodine)

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Use

INDICATIONS & USAGE SECTION

First aid to help prevent skin infection in

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Ask a doctor if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites or serious burns

When using this product

OTC - WHEN USING SECTION

  • do not use in eyes or apply over large areas of the body
  • do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

SPL UNCLASSIFIED SECTION

product will stain skin and clothing

ADVERSE REACTION

ADVERSE REACTIONS SECTION

Vi-Jon One Swan Drive, Smyrna, TN 37167

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (47% v/v), purified water, sodium iodide

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOR EXTERNAL USE ONLY

Swan ®

Iodine Tincture U.S.P.

  • First Aid Antiseptic

CAUTION POISON

1 FL OZ (30 mL)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311093iodine 2 % Topical SolutionPSN3
311093iodine 20 MG/ML Topical SolutionSCD3
311093iodine 2 % tincture for Topical SolutionSY3
311093iodine 2 % Topical SolutionSY3

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
11344-880-10Iodine30 mL in 1 BOTTLE, PLASTICLIQUID303

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
11344-88011344-880-10

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
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
SODIUM IODIDEF5WR8N145CIACT
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
IodineIODINENice-Pak Products, LLC857f13fe-51c9-4e5b-b5e2-a981dedabf712026-03-12Warnings, Adverse reactionsExact identifier
ndc (package): 11344-880-10
ndc (product): 11344-880
ndc11 (package): 11344088010
spl id: 4cd627b7-4d2d-0a03-e063-6294a90ae4f7
spl set id: 857f13fe-51c9-4e5b-b5e2-a981dedabf71

Reported adverse events (FAERS/openFDA)#

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