FDA.reportPublic FDA data

Iodine Tincture

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC | Pharma Nobis, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:45:51

Label at a glance#

ProductIodine Tincture
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 2%

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 before use 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

OTC - STOP USE SECTION

if 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 Canter 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

TOPCO VIJA0622 QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Visit here for more information: topbrnds.com/4901ji

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare ®

health

Iodine Tincture USP

FIRST AID ANTISEPTIC

For External Use Only

CAUTION POISON

1 FL OZ (30 mL)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311093iodine 2 % Topical SolutionPSN6
311093iodine 20 MG/ML Topical SolutionSCD6
311093iodine 2 % tincture for Topical SolutionSY6
311093iodine 2 % Topical SolutionSY6

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
76162-088-10Iodine Tincture30 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS306

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-08876162-088-10

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
Iodine TinctureIODINE TINCTURETopco Associates LLCe648f206-cc4f-4f5f-b31c-2fb8bf2708a72026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 76162-088-10
ndc (product): 76162-088
ndc11 (package): 76162008810
spl id: 4ab7e252-0dd3-7c2f-e063-6394a90ab6b2
spl set id: e648f206-cc4f-4f5f-b31c-2fb8bf2708a7

Reported adverse events (FAERS/openFDA)#

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