FDA.reportPublic FDA data

Isopropyl Alcohol

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-06-01 01:48:19

Label at a glance#

ProductIsopropyl Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure15 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

Isopropyl alcohol 91%

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

SPL UNCLASSIFIED SECTION

  • Keep away from fire or flame, heat, spark, electrical
  • do not use as a fuel source

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if 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 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

WARNINGS AND 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

Other information

OTHER SAFETY INFORMATION

  • does not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive ingredients

INACTIVE INGREDIENT SECTION

water

Adverse reaction

ADVERSE REACTIONS SECTION

Vist us at: Rexall.com or call 1-866-4-REXALL

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 

Pat. D675, 101

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Since 1903

Rexall ™

91% Isopropyl Alcohol

First Aid Antiseptic

Topical Antimicrobial

  • For treatment of minor cuts and scrapes

WARNING FLAMMABLE

  • Keep away from heat, spark, electrical, fire or flame
  • Do not use as fuel source

CAUTION: Do not point at self or others; product will squirt when squeezed.

Use only as directed, in a well-ventilated area; fumes can be harmful

32 FL OZ (1 QT) 946 mL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN18
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD18
582901isopropyl alcohol 91 % Topical SolutionSY18

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-804-43Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID47318
55910-804-45Isopropyl Alcohol946 mL in 1 BOTTLE, PLASTICLIQUID94618

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
55910-80455910-804-43, 55910-804-45

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
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
Isopropyl AlcoholISOPROPYL ALCOHOLOld East Main Co.2a09f6c0-e9a6-4f48-bce1-6cf7345f2d872026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 55910-804-43
ndc (package): 55910-804-45
ndc (product): 55910-804
ndc11 (package): 55910080445
ndc11 (package): 55910080443
spl id: 4c0ffc25-fbb2-6ca4-e063-6394a90a277e
spl set id: 2a09f6c0-e9a6-4f48-bce1-6cf7345f2d87

Reported adverse events (FAERS/openFDA)#

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