FDA.reportPublic FDA data

Ethyl Rubbing Alcohol

Manufacturer
Cardinal Health | Vi-Jon Inc | Vi-Jon, Inc
Effective date
2018-11-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:45:15

Label at a glance#

ProductEthyl Rubbing Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Dosage and administration

clean the affected area apply a small amount of this product on the affected 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

Ethyl alcohol 70%

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

OTHER SAFETY INFORMATION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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.

For Rubbing & Massaging:

USER SAFETY WARNINGS SECTION

Caution - Do not apply to irritated skin or if excessive irritation develops.  Avoid getting into the eyes or mucous membranes.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

  • will product serious gastric disturbances if taken internally

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetone, denatonium benzoate, methyl isobutyl ketone, water

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

CIN 2369411  www.myleader.com  1-800-200-6313

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-979-43

LEADER

Ethyl Rubbing  Alcohol

70% by volume

First Aid Antiseptic

For Rubbing and Massaging

WARNING FLAMMABLE-Keep away from heat, spark, electrical, fire or flame

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

SATISFACTION GUARANTEED

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
37205-976-43ML - Milliliter37205-97614e06f45-dcc0-444d-b728-26e858cf0c9312013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163021
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163021
ACETONEINACTIVE INGREDIENT1364PS73AF1
DENATONIUM BENZOATEINACTIVE INGREDIENT4YK5Z54AT21
METHYL ISOBUTYL KETONEINACTIVE INGREDIENTU5T7B88CNP1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-97637205-976-43

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
ISOPROPYL ALCOHOLND2M416302ACTIB
ACETONE1364PS73AFIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
METHYL ISOBUTYL KETONEU5T7B88CNPIACT
WATER059QF0KO0RIACT

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 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DENATONIUM BENZOATEDENATONIUM BENZOATE4YK5Z54AT2SWAB / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
ACETONEACETONE1364PS73AFTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
DENATONIUM BENZOATEDENATONIUM BENZOATE4YK5Z54AT2SOLUTION / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
DENATONIUM BENZOATEDENATONIUM BENZOATE4YK5Z54AT2GEL / TOPICALNAExact identifier — unii candidate
3 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
08de476a-df84-4ed3-b53f-5edf91b69850ff6b5d48-471d-4c4e-9f55-fb38166412022023-10-13WarningsExact identifier
spl set id: ff6b5d48-471d-4c4e-9f55-fb3816641202

Reported adverse events (FAERS/openFDA)#

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