FDA.reportPublic FDA data

maxim 50% ISOPROPYL RUBBING ALCOHOL

Manufacturer
OSTL, INC. | WILSON MEDICINE COMPANY
Effective date
2019-12-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:02:13

Label at a glance#

Productmaxim 50% ISOPROPYL RUBBING ALCOHOL
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Dosage and administration

• Clean affected 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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (by volume)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol (50% Conc)

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact poison control center (1-800-222-1222) immediately.

INDICATIONS & USAGE SECTION

Uses • First aid to help prevent risk of infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only

• flammable, keep away from fire or flame, heat, electric spark

Ask a doctor before use if you have

• deep punctured wounds, animals bites or serious burns

When using this products

• 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 using this product if

• Condition persists or gets worse

Directions

DOSAGE & ADMINISTRATION SECTION

• Clean affected 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

INACTIVE INGREDIENT SECTION

Inactive ingredient Purified water

Other information

STORAGE AND HANDLING SECTION

• store at room temperature

• does not contain, nor is intended as a substitute for grain or ethyl alcohol, will produce serious gastric disturbances if taken internally.

SPL UNCLASSIFIED SECTION

Use only in a well ventilated area, Fumes may be harmful.

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

Made in India

Imported By : OSTL Inc.

5805 White Oak Ave Encino CA, 91416

WWW.OSTLTRADE.COM

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN6
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD6
616456isopropyl alcohol 50 % Topical SolutionSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69950-003-012023-01-30C16284748780-1f386c649-fdfb-0266-e053-dadaa90a7c1amaxim 50% ISOPROPYL RUBBING ALCOHOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69950-003-01maxim 50% ISOPROPYL RUBBING ALCOHOL355 mL in 1 BOTTLE, PLASTICLIQUID3556

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69950-003MAXIM 50% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [OSTL, INC.]6Legacy NDC, 1 package rows20191221_af280a3d-6770-4700-8aef-a40f89b71125.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163025
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163025
WATERINACTIVE INGREDIENT059QF0KO0R5

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
69950-00369950-003-01

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
8490a3b5-7190-45b0-8fe2-854972a3aba6af280a3d-6770-4700-8aef-a40f89b711252019-12-20WarningsExact identifier
spl id: 8490a3b5-7190-45b0-8fe2-854972a3aba6
spl set id: af280a3d-6770-4700-8aef-a40f89b71125

Reported adverse events (FAERS/openFDA)#

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