FDA.reportPublic FDA data

Isopropyl alcohol

Manufacturer
Universal Distribution Center LLC | Jell Pharmaceuticals Pvt. Ltd. | Jell Pharmaceuticals Pvt Ltd.
Effective date
2025-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:43

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 and burns.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (by volume)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol (91% conc.)

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external use only.

  • if taken  internally, serious gastic disturbance will result

Flammable, keep away from fire or flame.

  • use only in a well-ventilated area; fumes may be toxic

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 not apply over large areas of the body
  • do not use longer than one week unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

91% Isopropyl Alcohol

Antiseptic

  • Topical Antiseptic & Sanitizer
  • Antibacterial Cleansing Agent for Minor Cuts & Abrasions
  • Preparation of Skin Prior to an Injection

For question or comments call 1-888-287-1915.

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN1
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD1
582901isopropyl alcohol 91 % Topical SolutionSY1

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
52000-804-01Isopropyl alcohol355 mL in 1 BOTTLE, PLASTICLIQUID3551
52000-804-02Isopropyl alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-804ISOPROPYL ALCOHOL LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]1Current NDC, 2 package rows20250308_2f98a900-6c7c-0161-e063-6294a90ac675.zip

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
52000-80452000-804-01, 52000-804-02

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

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 ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
ndc (package): 52000-804-01
ndc (package): 52000-804-02
ndc (product): 52000-804
ndc11 (package): 52000080401
ndc11 (package): 52000080402
spl id: 2f98a910-873f-d80f-e063-6394a90a37e8
spl set id: 2f98a900-6c7c-0161-e063-6294a90ac675

Reported adverse events (FAERS/openFDA)#

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