FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol

Manufacturer
Pioneer Associates | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2012-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:51

Label at a glance#

ProductIsopropyl Rubbing Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (by volume)

Isopropyl alcohol (50% conc.)

OTC - PURPOSE SECTION

Purpose

first aid antiseptic

INDICATIONS & USAGE SECTION

Uses

  • first aid to help prevent risk of infection in:
  • minor cuts
  • scrapes
  • burns

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 - DO NOT USE SECTION

When using this product

  • do not get into eyes or mucous membranes
  • use in well-ventilated area: forms may be toxic

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 or 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 ingredient

Water (Aqua)

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

CAVALIER ISOPROPYL RUBBING ALCOHOL 50%

FIRST AID ANTISEPTIC

12 FL.OZ (354 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

alcohol-50alcohol-50

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
53033-001-012020-01-31C16284748780-19d75b9d0-5005-f424-e053-dadaa90a57ceCAVALIER ISOPROPYL RUBBING ALCOHOL 50%
53033-001-022020-01-31C16284748780-19d75b9d0-5005-f424-e053-dadaa90a57ceCAVALIER ISOPROPYL RUBBING ALCOHOL 50%
53033-001-032020-01-31C16284748780-19d75b9d0-5005-f424-e053-dadaa90a57ceCAVALIER ISOPROPYL RUBBING ALCOHOL 50%
53033-001-042020-01-31C16284748780-19d75b9d0-5005-f424-e053-dadaa90a57ceCAVALIER ISOPROPYL RUBBING ALCOHOL 50%
53033-001-052020-01-31C16284748780-19d75b9d0-5005-f424-e053-dadaa90a57ceCAVALIER ISOPROPYL RUBBING ALCOHOL 50%
53033-001-062020-01-31C16284748780-19d75b9d0-5005-f424-e053-dadaa90a57ceCAVALIER ISOPROPYL RUBBING ALCOHOL 50%
53033-001-072020-01-31C16284748780-19d75b9d0-5005-f424-e053-dadaa90a57ceCAVALIER ISOPROPYL RUBBING ALCOHOL 50%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53033-001-01Isopropyl Rubbing Alcohol119 mL in 1 BOTTLE, PLASTICLIQUID1191
53033-001-02Isopropyl Rubbing Alcohol178 mL in 1 BOTTLE, PLASTICLIQUID1781
53033-001-03Isopropyl Rubbing Alcohol237 mL in 1 BOTTLE, PLASTICLIQUID2371
53033-001-04Isopropyl Rubbing Alcohol295 mL in 1 BOTTLE, PLASTICLIQUID2951
53033-001-05Isopropyl Rubbing Alcohol354 mL in 1 BOTTLE, PLASTICLIQUID3541
53033-001-06Isopropyl Rubbing Alcohol414 mL in 1 BOTTLE, PLASTICLIQUID4141
53033-001-07Isopropyl Rubbing Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53033-001ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [PIONEER ASSOCIATES]1Legacy NDC, 7 package rows20120827_1be7caa2-37fe-4fd9-8251-50744017daa6.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
53033-00153033-001-01, 53033-001-02, 53033-001-03, 53033-001-04, 53033-001-05, 53033-001-06, 53033-001-07

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
ISOPROPYL ALCOHOLND2M416302ACTIM
WATER059QF0KO0RIACT

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
752587cb-6a25-4404-aad9-66269dbe10521be7caa2-37fe-4fd9-8251-50744017daa62012-08-24WarningsExact identifier
spl id: 752587cb-6a25-4404-aad9-66269dbe1052
spl set id: 1be7caa2-37fe-4fd9-8251-50744017daa6

Reported adverse events (FAERS/openFDA)#

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