FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol 50%

Manufacturer
FOUR SEASONS TRADING INC | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2014-11-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:55

Label at a glance#

ProductIsopropyl Rubbing Alcohol 50%
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (by volume)

Isopropyl alcohol (50% concentrate)

OTC - PURPOSE SECTION

Purpose

topical antimicrobial

INDICATIONS & USAGE SECTION

Uses

  • to decrease germs in minor cuts and scrapes
  • helps relieve minor muscular aches due to exertion

WARNINGS SECTION

Warnings

For external use only

  • flammable, keep away from fire and flame
  • will produce serious gastric disturbances if taken internally

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area

OTC - STOP USE SECTION

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

In case of an accidental ingestion, contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply to skin directly of with clean gauze, cotton or swab
  • for rubbing apply liberally and rub with hands

SPL UNCLASSIFIED SECTION

Other information

  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • keep bottle tightly closed

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 50%

TOPICAL ANTIMICROBIAL

12 FL.OZ (354 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130676979860015GTIN-13: 0676979860015
EAN-13: 0676979860015
GTIN-12: 676979860015
UPC-A: 676979860015
GTIN storage (14 digits): 00676979860015		isopropyl-alcohol.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69274-001-012020-01-31C16284748780-19d75b9d0-3a99-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
69274-001-022020-01-31C16284748780-19d75b9d0-3a99-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
69274-001-032020-01-31C16284748780-19d75b9d0-3a99-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
69274-001-042020-01-31C16284748780-19d75b9d0-3a99-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
69274-001-052020-01-31C16284748780-19d75b9d0-3a99-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
69274-001-062020-01-31C16284748780-19d75b9d0-3a99-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
69274-001-072020-01-31C16284748780-19d75b9d0-3a99-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69274-001-01Isopropyl Rubbing Alcohol 50%118 mL in 1 BOTTLE, PLASTICLIQUID1181
69274-001-02Isopropyl Rubbing Alcohol 50%177 mL in 1 BOTTLE, PLASTICLIQUID1771
69274-001-03Isopropyl Rubbing Alcohol 50%237 mL in 1 BOTTLE, PLASTICLIQUID2371
69274-001-04Isopropyl Rubbing Alcohol 50%296 mL in 1 BOTTLE, PLASTICLIQUID2961
69274-001-05Isopropyl Rubbing Alcohol 50%354 mL in 1 BOTTLE, PLASTICLIQUID3541
69274-001-06Isopropyl Rubbing Alcohol 50%414 mL in 1 BOTTLE, PLASTICLIQUID4141
69274-001-07Isopropyl Rubbing Alcohol 50%473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69274-001ISOPROPYL RUBBING ALCOHOL 50% (ISOPROPYL ALCOHOL) LIQUID [FOUR SEASONS TRADING INC]1Legacy NDC, 7 package rows20141125_9c3c055d-385a-486d-ae6f-de39af1d0884.zip

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 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69274-00169274-001-01, 69274-001-02, 69274-001-03, 69274-001-04, 69274-001-05, 69274-001-06, 69274-001-07

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
08b1f358-f446-5080-e054-00144ff8d46c9c3c055d-385a-486d-ae6f-de39af1d08842014-11-25WarningsExact identifier
spl id: 08b1f358-f446-5080-e054-00144ff8d46c
spl set id: 9c3c055d-385a-486d-ae6f-de39af1d0884

Reported adverse events (FAERS/openFDA)#

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