FDA.reportPublic FDA data

Iodine Tincture

Manufacturer
Laboratorios Jaloma, S.A. de C.V.
Effective date
2016-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:22:58

Label at a glance#

ProductIodine Tincture
Active ingredientIODINE, SODIUM IODIDE
Label structure12 sections

Indications and uses

First aid to help prevent infection in *minor cuts *scrapes *burns

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Iodine 2.0%

Sodium Iodide 2.4%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in *minor cuts *scrapes *burns

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use in the eyes or apply over large areas of

the body

Do not use longer than 1 week, unless directed by a

doctor

OTC - ASK DOCTOR SECTION

Consult a doctor in case of * deep or puncture

wounds * animal bites * serious burns

OTC - STOP USE SECTION

Stop use and consult a doctor if the condition

persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.  In case of

accidental ingestion, seek professional assistance

or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions  clean the affected area * apply a

small amount of this product on the area 1 to 3

times daily * may be covered with a sterile bandage

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol, water

OTC - QUESTIONS SECTION

Questions

(33) 3617 5010 (In Guadalajara, Jal. Mexico)

Iodine Tincture Topical Antiseptic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

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
65055-10265055-102-01

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
IODINE9679TC07X4ACTIB
SODIUM IODIDEF5WR8N145CACTIM

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
0022e80f-88a2-11b5-e063-6294a90a5b81b2a6641c-77e5-4a97-ab89-c7be0b35d6382023-07-10WarningsExact identifier
spl set id: b2a6641c-77e5-4a97-ab89-c7be0b35d638

Reported adverse events (FAERS/openFDA)#

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