FDA.reportPublic FDA data

Isopropyl Alcohol

Manufacturer
Cardinal Health | Vi-Jon, LLC
Effective date
2021-06-10
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 22:43:42

Label at a glance#

ProductIsopropyl Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 91%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Use

INDICATIONS & USAGE SECTION

first aid to help prevent the risk of infection in:

  • minor cuts 
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Flammable •keep away from fire or flame, heat, spark, electrical

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have deep or puncture wounds, animal bites or serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not apply over large areas of the body
  • do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists or gets worse

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 of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

OTHER SAFETY INFORMATION

  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • will product serious gastric disturbances if taken internally

Inactive ingredient

INACTIVE INGREDIENT SECTION

water

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-227-43

LEADER 91% Isopropyl Alcohol

First Aid Antiseptic

WARNING FLAMMABLE

Keep away from heat, spark, electrical, fire or flame

Use only in a well-ventilated area; fumes may be harmful

16 FL OZ (1 PT) 473 mL

image descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-227-43ML - Milliliter37205-227aea5c8c9-12ae-4b87-8c88-9c330c74213d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163021
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163021
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-22737205-227-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT

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
e4e20967-9624-4d2c-9274-7794dfd6f365d5cecbee-939d-430b-bf2d-28ec43a65d0e2021-06-30WarningsExact identifier
spl set id: d5cecbee-939d-430b-bf2d-28ec43a65d0e

Reported adverse events (FAERS/openFDA)#

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