FDA.reportPublic FDA data

50% Isopropyl Rubbing Alcohol

Manufacturer
AMERICAN CONSUMER PRODUCTS LLC | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2017-07-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:00

Label at a glance#

Product50% Isopropyl Rubbing Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (by volume)

Isopropyl alcohol (50% conc.)

OTC - PURPOSE SECTION

Purpose

Topical Antimicrobial

INDICATIONS & USAGE SECTION

Uses

  • 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 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 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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

50% ISOPROPYL RUBBING ALCOHOL

Topical Antimicrobial

12 FL.OZ (354 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-130757437916021GTIN-13: 0757437916021
EAN-13: 0757437916021
GTIN-12: 757437916021
UPC-A: 757437916021
GTIN storage (14 digits): 00757437916021		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
18027-002-012020-01-31C16284748780-19d75b9d0-601f-f424-e053-dadaa90a57ce50% Isopropyl Rubbing Alcohol
18027-002-022020-01-31C16284748780-19d75b9d0-601f-f424-e053-dadaa90a57ce50% Isopropyl Rubbing Alcohol
18027-002-032020-01-31C16284748780-19d75b9d0-601f-f424-e053-dadaa90a57ce50% Isopropyl Rubbing Alcohol
18027-002-042020-01-31C16284748780-19d75b9d0-601f-f424-e053-dadaa90a57ce50% Isopropyl Rubbing Alcohol
18027-002-052020-01-31C16284748780-19d75b9d0-601f-f424-e053-dadaa90a57ce50% Isopropyl Rubbing Alcohol
18027-002-062020-01-31C16284748780-19d75b9d0-601f-f424-e053-dadaa90a57ce50% Isopropyl Rubbing Alcohol
18027-002-072020-01-31C16284748780-19d75b9d0-601f-f424-e053-dadaa90a57ce50% Isopropyl Rubbing Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
18027-002-0150% Isopropyl Rubbing Alcohol118 mL in 1 BOTTLE, PLASTICLIQUID1181
18027-002-0250% Isopropyl Rubbing Alcohol177 mL in 1 BOTTLE, PLASTICLIQUID1771
18027-002-0350% Isopropyl Rubbing Alcohol237 mL in 1 BOTTLE, PLASTICLIQUID2371
18027-002-0450% Isopropyl Rubbing Alcohol296 mL in 1 BOTTLE, PLASTICLIQUID2961
18027-002-0550% Isopropyl Rubbing Alcohol354 mL in 1 BOTTLE, PLASTICLIQUID3541
18027-002-0650% Isopropyl Rubbing Alcohol414 mL in 1 BOTTLE, PLASTICLIQUID4141
18027-002-0750% Isopropyl Rubbing Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
18027-00250% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [AMERICAN CONSUMER PRODUCTS LLC]1Legacy NDC, 7 package rows20170720_416798cb-697a-42cf-8a7c-3d17aebfe228.zip

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
18027-00218027-002-01, 18027-002-02, 18027-002-03, 18027-002-04, 18027-002-05, 18027-002-06, 18027-002-07

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
54c3a2d6-5dfc-2d7b-e054-00144ff88e88416798cb-697a-42cf-8a7c-3d17aebfe2282017-07-20WarningsExact identifier
spl id: 54c3a2d6-5dfc-2d7b-e054-00144ff88e88
spl set id: 416798cb-697a-42cf-8a7c-3d17aebfe228

Reported adverse events (FAERS/openFDA)#

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