FDA.reportPublic FDA data

GNP Isopropyl Alcohol 50 Percent

Manufacturer
Amerisource Bergen
Effective date
2016-06-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:10

Label at a glance#

ProductGNP Isopropyl Alcohol 50 Percent
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

clean the affected area. apply a small amount of this product on the affected area 1 to 3 times daily. may be covered with sterile bandage. if bandaged, let it dry first..

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 50% by volume

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Use

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 way from spark, heat and flame.

Ask a doctor before use for

OTC - ASK DOCTOR SECTION

  • deep wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes. 
  • do not apply over large areas of the body
  • do not use longer than 1 week

Stop use and ask a doctor if

OTC - STOP USE SECTION

If condition persists or gets worse.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area.
  • apply a small amount of this product on the affected area 1 to 3 times daily.
  • may be covered with sterile bandage.
  • if bandaged, let it dry first..

Other Information

OTHER SAFETY INFORMATION

  • store at controlled room temperature
  • 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

NDC 46122-328-45
ISOPROPYL
RUBBING
ALCOHOL 50%
USP
First Aid Antiseptic
32 fl oz (1 QT) 946 mL

NDC 46122-328-45 ISOPROPYL RUBBING ALCOHOL 50% USP First Aid Antiseptic 32 fl oz (1 QT) 946 mLNDC 46122-328-45 ISOPROPYL RUBBING ALCOHOL 50% USP First Aid Antiseptic 32 fl oz (1 QT) 946 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN1
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD1
616456isopropyl alcohol 50 % Topical SolutionSY1

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-328-432022-07-29C16284748780-1e4f33bdf-adfe-d8a0-e053-dadaa90a6e4eGNP Isopropyl Alcohol 50 Percent USP
46122-328-452022-07-29C16284748780-1e4f33bdf-adfe-d8a0-e053-dadaa90a6e4eGNP Isopropyl Alcohol 50 Percent USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-328-43GNP Isopropyl Alcohol 50 Percent473 mL in 1 BOTTLELIQUID4731
46122-328-45GNP Isopropyl Alcohol 50 Percent946 mL in 1 BOTTLELIQUID9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-328GNP ISOPROPYL ALCOHOL 50 PERCENT (ISOPROPYL ALCOHOL) LIQUID [AMERISOURCE BERGEN]1Legacy NDC, 2 package rows20160602_12586845-f010-4f6f-922e-cf140e44c24f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-328-43ML - Milliliter46122-3288842a72a-0b99-485b-85af-691cf8f50c5f12022-06-06
46122-328-45ML - Milliliter46122-328f523b337-a99d-46a4-8edc-5c4925126f2f12022-06-06

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
46122-32846122-328-43, 46122-328-45

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
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
a58e624b-ae9e-465d-adad-98ffdab6b5b312586845-f010-4f6f-922e-cf140e44c24f2016-06-06WarningsExact identifier
spl id: a58e624b-ae9e-465d-adad-98ffdab6b5b3
spl set id: 12586845-f010-4f6f-922e-cf140e44c24f

Reported adverse events (FAERS/openFDA)#

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