FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol 50%

Manufacturer
North & South Wholesalers LLC | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2015-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:57

Label at a glance#

ProductIsopropyl Rubbing Alcohol 50%
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (by volume)

Isopropyl alcohol (50% conc.)

OTC - PURPOSE SECTION

Purpose

First aid antiseptic

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only; flammable, keep away from fire or flame, heat, spark, electrical

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • deep punctured wounds, animal bites or serious burns

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - STOP USE SECTION

Stop using this product if

  • condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1212) immediately

DOSAGE & ADMINISTRATION SECTION

Directions

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

SPL UNCLASSIFIED SECTION

Other information

  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol, will produce serious gastric disturbance if taken internally

INACTIVE INGREDIENT SECTION

Inactive Ingredient

purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 50%

FIRST AID ANTISEPTIC

12 FL.OZ (355 mL)

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-130676979390130GTIN-13: 0676979390130
EAN-13: 0676979390130
GTIN-12: 676979390130
UPC-A: 676979390130
GTIN storage (14 digits): 00676979390130		isopropyl-alcohol.jpg

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
70201-001-012020-01-31C16284748780-19d75b9cf-f65f-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
70201-001-022020-01-31C16284748780-19d75b9cf-f65f-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
70201-001-032020-01-31C16284748780-19d75b9cf-f65f-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
70201-001-042020-01-31C16284748780-19d75b9cf-f65f-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
70201-001-052020-01-31C16284748780-19d75b9cf-f65f-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
70201-001-062020-01-31C16284748780-19d75b9cf-f65f-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%
70201-001-072020-01-31C16284748780-19d75b9cf-f65f-f424-e053-dadaa90a57ceIsopropyl Rubbing Alcohol 50%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70201-001-01Isopropyl Rubbing Alcohol 50%118 mL in 1 BOTTLE, PLASTICLIQUID1181
70201-001-02Isopropyl Rubbing Alcohol 50%177 mL in 1 BOTTLE, PLASTICLIQUID1771
70201-001-03Isopropyl Rubbing Alcohol 50%237 mL in 1 BOTTLE, PLASTICLIQUID2371
70201-001-04Isopropyl Rubbing Alcohol 50%296 mL in 1 BOTTLE, PLASTICLIQUID2961
70201-001-05Isopropyl Rubbing Alcohol 50%355 mL in 1 BOTTLE, PLASTICLIQUID3551
70201-001-06Isopropyl Rubbing Alcohol 50%414 mL in 1 BOTTLE, PLASTICLIQUID4141
70201-001-07Isopropyl Rubbing Alcohol 50%473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70201-001ISOPROPYL RUBBING ALCOHOL 50% (ISOPROPYL ALCOHOL) LIQUID [NORTH & SOUTH WHOLESALERS LLC]1Legacy NDC, 7 package rows20151104_1648c393-756c-4792-ad74-83d1a3b52f95.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
70201-00170201-001-01, 70201-001-02, 70201-001-03, 70201-001-04, 70201-001-05, 70201-001-06, 70201-001-07

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
23bbacc3-c6e0-500c-e054-00144ff88e881648c393-756c-4792-ad74-83d1a3b52f952015-11-04WarningsExact identifier
spl id: 23bbacc3-c6e0-500c-e054-00144ff88e88
spl set id: 1648c393-756c-4792-ad74-83d1a3b52f95

Reported adverse events (FAERS/openFDA)#

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