FDA.reportPublic FDA data

Isopropyl Alcohol

Manufacturer
TOP CARE (Topco Associates LLC)
Effective date
2024-11-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:36:56

Label at a glance#

ProductIsopropyl Alcohol 50 Percent
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (by volume)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol (50% conc.)

Purpose

OTC - PURPOSE SECTION

first aid antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

  • if taken internally, serious gastric disturbances will result

Flammable, keep away from fire or flame.

  • use only in a well-ventilated area; fumes may be toxic

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites or serious burns

When using this product

OTC - WHEN USING SECTION

  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50% Isopropyl Alcohol

FIRST AID ANTISEPTIC

Helps prevent the risk of infection in:

  • Minor cuts
  • Minor scrapes
  • Minor burns

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by Topco Associates LLC

Elk Grove Village, IL 60007

topcare@topco.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPCARE HEALTH 50% Isopropyl Alcohol
TOPCARE HEALTH 50% Isopropyl Alcohol

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-071-162021-02-20C16284748780-19d75b9d0-e2ff-f424-e053-dadaa90a57ceDrug Facts
36800-071-162020-01-31C16284748780-19d75b9d0-e2ff-f424-e053-dadaa90a57ceDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-071ISOPROPYL ALCOHOL 50 PERCENT (ISOPROPYL ALCOHOL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]8Legacy NDC20241115_03fc2595-20bd-4863-bd6f-d80f23be7e11.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
36800-07136800-071-16

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 ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT

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
5b94d256-659d-48e6-b617-cd03dded12c203fc2595-20bd-4863-bd6f-d80f23be7e112024-11-13WarningsExact identifier
spl id: 5b94d256-659d-48e6-b617-cd03dded12c2
spl set id: 03fc2595-20bd-4863-bd6f-d80f23be7e11

Reported adverse events (FAERS/openFDA)#

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