FDA.reportPublic FDA data

Sunmark Iodides Tincture

Manufacturer
Strategic Sourcing Services LLC | Pharma Nobis, LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:04:56

Label at a glance#

ProductSunmark Iodides Tincture
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 48%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic                        

Use

INDICATIONS & USAGE SECTION

first aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire or flame

SPL UNCLASSIFIED SECTION

When using this product

OTC - WHEN USING SECTION

do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and consult doctor if the

OTC - STOP USE SECTION

condition persists or gets worse. Do not use this product for longer than 1 week unless directed by a doctor.

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 sterile bandage.
  • if bandaged, let dry first.

Other information

OTHER SAFETY INFORMATION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, iodine, potassium iodide, and purified water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

labellabel

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
49348-711-30Sunmark Iodides Tincture59 mL in 1 BOTTLELIQUID596

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-711SUNMARK IODIDES TINCTURE (ETHYL ALCOHOL) LIQUID [STRATEGIC SOURCING SERVICES LLC]6Current NDC, Legacy NDC, 1 package rows20231220_5e227f79-fca7-4633-97ea-61da4060fe92.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-711-30ML - Milliliter49348-7115256da10-74d4-4812-872d-7a4be9e931cf12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
AMMONIAINACTIVE INGREDIENT5138Q19F1X1
IODINEINACTIVE INGREDIENT9679TC07X41
POTASSIUM IODIDEINACTIVE INGREDIENT1C4QK22F9J1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
49348-71149348-711-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
AMMONIA5138Q19F1XIACT
IODINE9679TC07X4IACT
POTASSIUM IODIDE1C4QK22F9JIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AMMONIAAMMONIA SOLUTION5138Q19F1XLOTION / TOPICALADJ PHExact identifier — unii+route
6 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XCREAM / TOPICAL5.72 %w/wExact identifier — unii+route
6 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XGEL / TOPICAL1.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XLOTION / TOPICALADJ PHExact identifier — unii+route
6 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XGEL / TOPICAL1.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XCREAM / TOPICAL5.72 %w/wExact identifier — unii+route
6 equally ranked IID candidates

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 Iodides TinctureETHYL ALCOHOLStrategic Sourcing Services LLC5e227f79-fca7-4633-97ea-61da4060fe922023-12-19WarningsExact identifier
ndc (package): 49348-711-30
ndc (product): 49348-711
ndc11 (package): 49348071130
spl id: 0ce5bdec-f4ff-73d9-e063-6294a90a6a87
spl set id: 5e227f79-fca7-4633-97ea-61da4060fe92

Reported adverse events (FAERS/openFDA)#

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