FDA.reportPublic FDA data

Isopropyl Alcohol

Manufacturer
Hydrox Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:32:22

Label at a glance#

ProductIsopropyl Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure9 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 1 to 3 times daily

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

SPL UNCLASSIFIED SECTION

  • keep away from fire or flame, heat, spark, electrical. Flash point 72°F.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you havedeep or puncture wounds, animal bites or serious burns

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor ifcondition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply 1 to 3 times daily

Other information

STORAGE AND HANDLING 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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrox

TRADEMARK
SINCE 1913

Warning
Flammable

ISOPROPYL ALCOHOL

91%

TAMPER EVIDENT CAP FOR YOUR PROTECTION.

IF RING-BAND IS DETACHED FROM CAP OR MISSING DO NOT USE.

Principal Display PanelPrincipal Display Panel

Hydrox LABORATORIES

Elgin, IL 60123

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN12
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD12
582901isopropyl alcohol 91 % Topical SolutionSY12

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130021599412913GTIN-13: 0021599412913
EAN-13: 0021599412913
GTIN-12: 021599412913
UPC-A: 021599412913
GTIN storage (14 digits): 00021599412913		isprpopylalcohol.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10565-071-04Isopropyl Alcohol118 mL in 1 BOTTLE, PLASTICLIQUID11812
10565-071-08Isopropyl Alcohol237 mL in 1 BOTTLE, PLASTICLIQUID23712
10565-071-16Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID47312
10565-071-32Isopropyl Alcohol946 mL in 1 BOTTLE, PLASTICLIQUID94612
10565-071-99Isopropyl Alcohol3785 mL in 1 BOTTLE, PLASTICLIQUID378512

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
10565-07110565-071-04, 10565-071-08, 10565-071-32, 10565-071-16, 10565-071-99

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 · 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
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratoriesf2f07464-6bd5-434c-8dea-0ba659c0e5492026-01-12WarningsExact identifier
ndc (package): 10565-071-04
ndc (package): 10565-071-08
ndc (package): 10565-071-32
ndc (package): 10565-071-99
ndc (package): 10565-071-16
ndc (product): 10565-071
ndc11 (package): 10565007116
ndc11 (package): 10565007104
ndc11 (package): 10565007199
ndc11 (package): 10565007108
ndc11 (package): 10565007132
spl id: 483361ef-6aaf-631d-e063-6394a90a0f59
spl set id: f2f07464-6bd5-434c-8dea-0ba659c0e549

Reported adverse events (FAERS/openFDA)#

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