FDA.reportPublic FDA data

HUMCO 1 Percent Iodine

Manufacturer
Humco Holding Group, Inc. | Pharma Nobis, LLC | Pharma Nobis
Effective date
2025-09-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:14:23

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

Isopropyl Alcohol 70%

Purpose

Topical antiseptic

Uses

Indications

Preoperative skin preparation. Helps to reduce skin bacteria that potentially can cause skin infection.

Warnings

Warnings :

Flammable: Keep away from spark, heat or flame. Do not use with electrocautery procedures. For external use only.

Directions And Dosage

Directions

Use only by trained personnel. Clean the affected area. Apply product to operative site prior to surgery. When this product dries remove immediately with 70% alcohol or as directed by a physician.

Other Label Information

Inactive Ingredient

Iodine 1%, Potassium iodide, Purified water.

PRINCIPAL DISPLAY PANEL

Label Images#

1 Iodine Label
1 Iodine Label
capture
capture

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN4
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD4
808520isopropyl alcohol 70 % Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
0395-1211-162025-09-22C16284748780-1e4f33bdf-9e3d-d8a0-e053-dadaa90a6e4eIodine Tincture 1 percent
0395-1211-162022-07-29C16284748780-1e4f33bdf-9e3d-d8a0-e053-dadaa90a6e4eIodine Tincture 1 percent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-1211-16HUMCO 1 Percent Iodine473 mL in 1 BOTTLE, PLASTICLIQUID4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-1211-16ML - Milliliter0395-1211f94e1cce-3e40-44bb-91be-2f8140cac57412020-03-10

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-12110395-1211-16

Ingredients#

Name, UNII, Kind table
NameUNIIKind
IODINE9679TC07X4IACT
POTASSIUM IODIDE1C4QK22F9JIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

HUMCO 1% Iodine Tincture Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Topical antiseptic

Indications

INDICATIONS & USAGE SECTION

Preoperative skin preparation. Helps to reduce skin bacteria that potentially can cause skin infection.

Warnings :

WARNINGS SECTION

Flammable: Keep away from spark, heat or flame. Do not use with electrocautery procedures. For external use only.

Directions

DOSAGE & ADMINISTRATION SECTION

Use only by trained personnel. Clean the affected area. Apply product to operative site prior to surgery. When this product dries remove immediately with 70% alcohol or as directed by a physician.

Other Information

OTHER SAFETY INFORMATION

Will stain skin and clothing. Store at room temperature.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Iodine 1%, Potassium iodide, Purified water.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML