FDA.reportPublic FDA data

Sunmark Iodine

Manufacturer
Strategic Sourcing Services LLC | Pharma Nobis, LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:05:02

Label at a glance#

ProductSunmark Iodine
Active ingredientIODINE, ALCOHOL, SODIUM IODIDE
Label structure8 sections

Indications and uses

To help prevent infection in minor cuts, scrapes and burns.

Dosage and administration

Clean the affected area.  Apply a small amount to the affected area 1 to 3 times daily.  May be covered with a sterile bandage.  If bandaged, let dry first.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Iodine  2%,  Sodium Iodide 2.4%,  Alcohol 47%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To help prevent infection in minor cuts, scrapes and burns.

WARNINGS:

WARNINGS SECTION

For external use only.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Clean the affected area.  Apply a small amount to the affected area 1 to 3 times daily.  May be covered with a sterile bandage.  If bandaged, let dry first.

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Purified Water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IodineIodine

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
49348-133-272020-03-18C16284748780-19d75b9d1-1b36-f424-e053-dadaa90a57ceSunmark Iodine Tincture USP 2%
49348-133-272020-01-31C16284748780-19d75b9d1-1b36-f424-e053-dadaa90a57ceSunmark Iodine Tincture USP 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-133-27Sunmark Iodine30 mL in 1 BOTTLETINCTURE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-133SUNMARK IODINE (IODINE, SODIUM IODIDE, ALCOHOL) TINCTURE [STRATEGIC SOURCING SERVICES LLC]7Current NDC, Legacy NDC, 1 package rows20231220_e8dae2d6-58b1-4c4e-a4c1-371db055b7ae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-133-27ML - Milliliter49348-13318138ccb-dca7-476d-a19b-d7cd7f03646212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M2
IODINEACTIVE INGREDIENT9679TC07X42
SODIUM IODIDEACTIVE INGREDIENTF5WR8N145C2
ALCOHOLACTIVE MOIETY3K9958V90M2
IODINEACTIVE MOIETY9679TC07X42
SODIUM CATIONACTIVE MOIETYLYR4M0NH372
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49348-13349348-133-27

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
IODINE9679TC07X4ACTIB
ALCOHOL3K9958V90MACTIB
SODIUM IODIDEF5WR8N145CACTIM

Source Document#

Source XML · Source PDF

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
Sunmark IodineIODINE, SODIUM IODIDE, ALCOHOLStrategic Sourcing Services LLCe8dae2d6-58b1-4c4e-a4c1-371db055b7ae2023-12-19WarningsExact identifier
ndc (package): 49348-133-27
ndc (product): 49348-133
ndc11 (package): 49348013327
spl id: 0ce55ce7-d710-5b31-e063-6294a90a7ab7
spl set id: e8dae2d6-58b1-4c4e-a4c1-371db055b7ae

Reported adverse events (FAERS/openFDA)#

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