FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol

Manufacturer
Healthwell
Effective date
2020-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:10

Label at a glance#

ProductIsopropyl Rubbing Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure12 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 1 to 3 times daily

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

Flammable

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

Do not use with electrocautery procedures

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 ot apply over large areas of the body

● do not use longer than 1 week unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if 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 1 to 3 times daily

Other Information

SPL UNCLASSIFIED SECTION

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

Will produce serious gastric disturbances if taken internally

Inactive Ingredient

INACTIVE INGREDIENT SECTION

purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TAMPER EVIDENT CAP FOR YOUR PROTECTION. IF RING-BAND IS DETACHED FROM CAP OR MISSING DO NOT USE.

Part # HSN2237

NDC #87010-004-32

Isopropyl Rubbing Alcohol 91%

FIRST AID ANTISEPTIC

Isopropyl AlcoholIsopropyl Alcohol

Manufactured for Healthwell

32 FL OZ

(946 mL)

Isopropyl AlcoholIsopropyl Alcohol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN3
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD3
582901isopropyl alcohol 91 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
87010-004-162022-01-28C16284748780-1d6a99b39-959c-a426-e053-dadaa90af4c2Isopropyl Alcohol 91%
87010-004-322022-01-28C16284748780-1d6a99b39-959c-a426-e053-dadaa90af4c2Isopropyl Alcohol 91%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87010-004-16Isopropyl Rubbing Alcohol473 mL in 1 BOTTLE, PLASTICSOLUTION4733
87010-004-32Isopropyl Rubbing Alcohol946 mL in 1 BOTTLE, PLASTICSOLUTION9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
87010-004ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) SOLUTION [HEALTHWELL]3Legacy NDC, 2 package rows20201008_941bfca4-0f6e-4c19-9c71-74a56dd3fbef.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87010-00487010-004-16, 87010-004-32

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 · Source PDF

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
1ae59392-b338-49e5-b176-00796b80999b941bfca4-0f6e-4c19-9c71-74a56dd3fbef2020-10-07WarningsExact identifier
spl id: 1ae59392-b338-49e5-b176-00796b80999b
spl set id: 941bfca4-0f6e-4c19-9c71-74a56dd3fbef

Reported adverse events (FAERS/openFDA)#

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