FDA.reportPublic FDA data

Ethyl Rubbing Alcohol

Manufacturer
Cardinal Health, 110 dba Leader | Nice-Pak Products, LLC
Effective date
2026-01-29
Label type
HUMAN OTC DRUG LABEL
Version
19
Source
full-release
Hydrated at
2026-06-01 01:36:01

Label at a glance#

ProductEthyl Rubbing Alcohol
Active ingredientALCOHOL
Label structure14 sections

Indications and uses

first aid to help prevent the risk of infection in: minor cuts scrapes burns

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

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only. If taken internally serious gastric disturbances will result.

Flammable 

  • keep away from fire or flame, heat spark, electrical
  • do not use as a fuel source. If exposed to a heat source, vapors may ignite, resulting in severe burns, serious injury, or death.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

for deep or puncture wounds, animal bites or serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not inhale
  • do not apply over large areas of the body
  • do not use longer than 1 week
  • use only as directed

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.

Caution

PRECAUTIONS SECTION

Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetone, denatonium benzoate, methyl isobutyl ketone, water

Questions?

OTC - QUESTIONS SECTION

1-888-593-0593

Adverse event

ADVERSE REACTIONS SECTION

DSP-TN-21091 DSP-MO-20087

DIST. BY CAH DUBLIN, OH 43017

www.myleader.com      

1-800-200-6313

©2025 Cardinal Health.

CIN 5516059   REV. 11/25

Pat. D675, 101

Principal Panel Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0020-1

Ethyl Rubbing Alcohol

70% by Volume

First Aid Antiseptic

For Rubbing and Massaging

100% Money Back Guarantee

WARNING FLAMMABLE

  • Keep away from heat, spark, electrical, fire or flame
  • DANGER: DO NOT USE AS A FUEL SOURCE. If exposed to a heat source, vapors may ignite, resulting in sever burns, serious injury, or death.

USE ONLY AS DIRECTED, IN A WELL-VENTILATED AREA; FUMES CAN BE HARMFUL.

CAUTION: DO NOT POINT AT SELF OR OTHERS; PRODUCT WILL SQUIRT WHEN SQUEEZED.

16 FL OZ (1 PT) 473 mL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN19
582753ethanol 0.7 ML/ML Topical SolutionSCD19
582753ethanol 70 % Topical SolutionSY19
582753ethyl alcohol 70 % Topical SolutionSY19

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0012701FDmm01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0020-1Ethyl Rubbing Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID47319

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0020-1ML - Milliliter70000-0020d5e20a74-4f42-464e-961f-e9f2d1449a4312019-11-12

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
70000-002070000-0020-1

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
ACETONE1364PS73AFIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
METHYL ISOBUTYL KETONEU5T7B88CNPIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
182025-12-26monthly-update2026-06-03 17:46:41

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
Ethyl Rubbing AlcoholETHYL ALCOHOLCardinal Health, 110 dba Leaderc56cbcbf-8e0e-4dff-80d3-df420c500a932026-01-29Warnings, Adverse reactionsExact identifier
ndc (package): 70000-0020-1
ndc (product): 70000-0020
ndc11 (package): 70000002001
spl id: 498e9e44-76a4-4afc-e063-6394a90a8ee5
spl set id: c56cbcbf-8e0e-4dff-80d3-df420c500a93

Reported adverse events (FAERS/openFDA)#

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