FDA.reportPublic FDA data

Isopropyl Alcohol 50%

Manufacturer
Hydrox Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:32:20

Label at a glance#

ProductIsopropyl Alcohol 50%
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Isopropyl Alcohol 50%

OTC - PURPOSE SECTION

Purpose:

First Aid Antiseptic

INDICATIONS & USAGE SECTION

Usesfirst aid to help prevent the risk of infection in: minor cuts, scrapes, burns.

WARNINGS SECTION

Warnings For external use only

Flammable

  • Keep away from fire or flame, heat, spark, electrical. Flash point 72°F.
  • do not use with eletocautery procedures.

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

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

Stop use and ask a doctor if condition 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.

DOSAGE & ADMINISTRATION SECTION

<Directions clean the affected area. apply 1 to 3 times daily.

WARNINGS AND PRECAUTIONS SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredient purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrox

Isopropyl Rubbing Alcohol

A cooling and refreshing and massaging compound

50%

First Aid Antiseptic

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

WARNING: FLAMMABLE!

Hydrox Laboratories

Elgin, IL 60123

isopropylalcoholisopropylalcohol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN14
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD14
616456isopropyl alcohol 50 % Topical SolutionSY14

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130021599412838GTIN-13: 0021599412838
EAN-13: 0021599412838
GTIN-12: 021599412838
UPC-A: 021599412838
GTIN storage (14 digits): 00021599412838		Isopropylalcohol.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10565-003-04Isopropyl Alcohol 50%118 mL in 1 BOTTLE, PLASTICSOLUTION11814
10565-003-08Isopropyl Alcohol 50%237 mL in 1 BOTTLE, PLASTICSOLUTION23714
10565-003-16Isopropyl Alcohol 50%473 mL in 1 BOTTLE, PLASTICSOLUTION47314
10565-003-32Isopropyl Alcohol 50%946 mL in 1 BOTTLE, PLASTICSOLUTION94614
10565-003-99Isopropyl Alcohol 50%3785 mL in 1 BOTTLE, PLASTICSOLUTION378514

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
10565-00310565-003-04, 10565-003-08, 10565-003-16, 10565-003-32, 10565-003-99

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
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT

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 Alcohol 50%ISOPROPYL ALCOHOL 50%Hydrox Laboratories930bb3a3-5ca3-414c-b4fb-c71ee17fc7462026-01-12WarningsExact identifier
ndc (package): 10565-003-08
ndc (package): 10565-003-99
ndc (package): 10565-003-04
ndc (package): 10565-003-32
ndc (package): 10565-003-16
ndc (product): 10565-003
ndc11 (package): 10565000304
ndc11 (package): 10565000399
ndc11 (package): 10565000316
ndc11 (package): 10565000308
ndc11 (package): 10565000332
spl id: 4833395f-8efc-471c-e063-6394a90a175e
spl set id: 930bb3a3-5ca3-414c-b4fb-c71ee17fc746

Reported adverse events (FAERS/openFDA)#

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