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

Label at a glance#

ProductHUMCO 1 Percent Iodine

Active ingredientISOPROPYL ALCOHOL

Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

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.

Do not use

OTC - DO NOT USE SECTION

in the eyes

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

IF ON SKIN:Wash with plenty of soap and water.

IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If skin irritation or rash occurs of if eye irritation persists, get medical advice/attention. Take off contaminated clothing and wash before reuse.

IN CASE OF FIRE:Use dry sand, dry chemical or alcohol resistant foam to extinguish. Store in well ventilated place. Keep cool. Dispose contents/container to an approved waste disposal plant.

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

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

1 Iodine Labelcapture

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
808520	isopropyl alcohol 70 % Topical Solution	PSN	4
808520	isopropyl alcohol 0.7 ML/ML Topical Solution	SCD	4
808520	isopropyl alcohol 70 % Topical Solution	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0395-1211-16	2025-09-22	C162847	48780-1	e4f33bdf-9e3d-d8a0-e053-dadaa90a6e4e	Iodine Tincture 1 percent
0395-1211-16	2022-07-29	C162847	48780-1	e4f33bdf-9e3d-d8a0-e053-dadaa90a6e4e	Iodine Tincture 1 percent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-1211-16	HUMCO 1 Percent Iodine	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-1211-16	ML - Milliliter	0395-1211	f94e1cce-3e40-44bb-91be-2f8140cac574	1	2020-03-10

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

HUMCO 1 Percent Iodine
Isopropyl Alcohol
IODINE
POTASSIUM IODIDE
WATER

NDC Codes#

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

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
Name	UNII	Kind
IODINE	9679TC07X4	IACT
POTASSIUM IODIDE	1C4QK22F9J	IACT
WATER	059QF0KO0R	IACT
ISOPROPYL ALCOHOL	ND2M416302	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HUMCO 1 Percent Iodine	ISOPROPYL ALCOHOL	Humco Holding Group, Inc.	139efeef-be20-4362-a5ba-158b8fa40e0d	2025-09-22	Warnings	Exact identifier ndc (package): 0395-1211-16 ndc (product): 0395-1211 ndc11 (package): 00395121116 spl id: 3f638681-b7bc-0ef0-e063-6294a90a4512 spl set id: 139efeef-be20-4362-a5ba-158b8fa40e0d

Reported adverse events (FAERS/openFDA)#

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