FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol

Manufacturer
Home Smart Products | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2018-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:06

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% 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 - DO NOT USE 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 ingredient

Water

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

HEALTH SMART ISOPROPYL RUBBING ALCOHOL 50%

TOPICAL ANTIMICROBIAL

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 SolutionPSN2
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD2
616456isopropyl alcohol 50 % Topical SolutionSY2

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
52862-005-032020-01-31C16284748780-19d75b9d0-7486-f424-e053-dadaa90a57ceHEALTH SMART ISOPROPYL RUBBING ALCOHOL 50%
52862-005-042020-01-31C16284748780-19d75b9d0-7486-f424-e053-dadaa90a57ceHEALTH SMART ISOPROPYL RUBBING ALCOHOL 50%
52862-005-062020-01-31C16284748780-19d75b9d0-7486-f424-e053-dadaa90a57ceHEALTH SMART ISOPROPYL RUBBING ALCOHOL 50%
52862-005-092020-01-31C16284748780-19d75b9d0-7486-f424-e053-dadaa90a57ceHEALTH SMART ISOPROPYL RUBBING ALCOHOL 50%
52862-005-102020-01-31C16284748780-19d75b9d0-7486-f424-e053-dadaa90a57ceHEALTH SMART ISOPROPYL RUBBING ALCOHOL 50%
52862-005-112020-01-31C16284748780-19d75b9d0-7486-f424-e053-dadaa90a57ceHEALTH SMART ISOPROPYL RUBBING ALCOHOL 50%
52862-005-122020-01-31C16284748780-19d75b9d0-7486-f424-e053-dadaa90a57ceHEALTH SMART ISOPROPYL RUBBING ALCOHOL 50%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-005-03Isopropyl Rubbing Alcohol119 mL in 1 BOTTLE, PLASTICLIQUID1192
52862-005-04Isopropyl Rubbing Alcohol178 mL in 1 BOTTLE, PLASTICLIQUID1782
52862-005-06Isopropyl Rubbing Alcohol237 mL in 1 BOTTLE, PLASTICLIQUID2372
52862-005-09Isopropyl Rubbing Alcohol295 mL in 1 BOTTLE, PLASTICLIQUID2952
52862-005-10Isopropyl Rubbing Alcohol354 mL in 1 BOTTLE, PLASTICLIQUID3542
52862-005-11Isopropyl Rubbing Alcohol414 mL in 1 BOTTLE, PLASTICLIQUID4142
52862-005-12Isopropyl Rubbing Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-005ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [HOME SMART PRODUCTS]2Legacy NDC, 7 package rows20190109_1a1d3bcf-c6b5-48fc-aa25-c6a7b9ff7bbe.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
52862-00552862-005-03, 52862-005-04, 52862-005-06, 52862-005-09, 52862-005-10, 52862-005-11, 52862-005-12

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
7e17941a-8d0a-ddb9-e053-2991aa0a84371a1d3bcf-c6b5-48fc-aa25-c6a7b9ff7bbe2018-12-28WarningsExact identifier
spl id: 7e17941a-8d0a-ddb9-e053-2991aa0a8437
spl set id: 1a1d3bcf-c6b5-48fc-aa25-c6a7b9ff7bbe

Reported adverse events (FAERS/openFDA)#

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