FDA.reportPublic FDA data

Decolorized Iodine

Manufacturer
Pharma Nobis, LLC
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:32

Label at a glance#

ProductDecolorized Iodine
Active ingredientALCOHOL
Label structure23 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 45 % denatured with ammonia, Ammonium and Potassium Iodides.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Stop use and ask a doctor if:

OTC - STOP USE SECTION

The condition persists or gets worse, or if using this product for longer than 1 week.

When using this product:

OTC - WHEN USING SECTION

Do not use in the eyes. If contact occurs, flush with large amounts of water while lifting upper and lower lids. Do not apply over large areas of the body.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of acidental ingestion give milk, then give a starch solution made by mixing two tablespoonfools of cornstarch or flour to a pint of water. contact a poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Purified Water

Other Information:

OTHER SAFETY INFORMATION

Will stain skin and clothing

De La Cruz Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DLCDLC

Good Neighbor Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNPGNP

Leader Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LeaderLeader

Quality Choice Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QCQC

Sunmark Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMSM

DDM Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DDMDDM

Rite Aid Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RARA

CVS Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Decolorized 2022CVS Decolorized 2022CVCCVC

Top Care Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TCTC

Vida Mia Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VMVM

Health Mart Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HMHM

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
82645-909-91Decolorized Iodine30 mL in 1 BOTTLE, PLASTICLIQUID302
82645-909-92Decolorized Iodine59 mL in 1 BOTTLE, PLASTICLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-909DECOLORIZED IODINE (ETHYL ALCOHOL) LIQUID [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 2 package rows20231223_e21dd43b-3712-cb16-e053-2a95a90ac276.zip

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
82645-90982645-909-92, 82645-909-91

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
AMMONIA5138Q19F1XIACT
IODINE9679TC07X4IACT
POTASSIUM IODIDE1C4QK22F9JIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
Decolorized IodineETHYL ALCOHOLPharma Nobis, LLCe21dd43b-3712-cb16-e053-2a95a90ac2762023-12-22WarningsExact identifier
ndc (package): 82645-909-91
ndc (package): 82645-909-92
ndc (product): 82645-909
ndc11 (package): 82645090992
ndc11 (package): 82645090991
spl id: 0d1ce3b4-41f8-98a4-e063-6394a90a7eaf
spl set id: e21dd43b-3712-cb16-e053-2a95a90ac276

Reported adverse events (FAERS/openFDA)#

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