FDA.reportPublic FDA data

Isopropyl Alcohol

Manufacturer
Hydrox Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:32:17

Label at a glance#

ProductIsopropyl Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Isopropyl Alcohol 70%

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, USP

A cooling and refreshing and massaging compound

70%

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
808520isopropyl alcohol 70 % Topical SolutionPSN14
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD14
808520isopropyl alcohol 70 % Topical SolutionSY14

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130021599123444GTIN-13: 0021599123444
EAN-13: 0021599123444
GTIN-12: 021599123444
UPC-A: 021599123444
GTIN storage (14 digits): 00021599123444		Isopropylalcohol.jpg

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
10565-002-04Isopropyl Alcohol118 mL in 1 BOTTLE, PLASTICSOLUTION11814
10565-002-08Isopropyl Alcohol237 mL in 1 BOTTLE, PLASTICSOLUTION23714
10565-002-16Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICSOLUTION47314
10565-002-32Isopropyl Alcohol946 mL in 1 BOTTLE, PLASTICSOLUTION94614
10565-002-99Isopropyl Alcohol3800 mL in 1 BOTTLE, PLASTICSOLUTION380014

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
10565-00210565-002-04, 10565-002-08, 10565-002-16, 10565-002-32, 10565-002-99

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 Laboratories2042cf29-52c5-4f1e-aae6-78e025994d182026-01-12WarningsExact identifier
ndc (package): 10565-002-04
ndc (package): 10565-002-16
ndc (package): 10565-002-08
ndc (package): 10565-002-32
ndc (package): 10565-002-99
ndc (product): 10565-002
ndc11 (package): 10565000204
ndc11 (package): 10565000216
ndc11 (package): 10565000208
ndc11 (package): 10565000299
ndc11 (package): 10565000232
spl id: 483384ed-390b-6ea7-e063-6394a90aaaaa
spl set id: 2042cf29-52c5-4f1e-aae6-78e025994d18

Reported adverse events (FAERS/openFDA)#

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