FDA.reportPublic FDA data

Isopropyl Alcohol 70 Percent

Manufacturer
Marlex Pharmaceuticals Inc
Effective date
2015-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:28

Label at a glance#

ProductIsopropyl Alcohol 70 Percent
Active ingredientISOPROPYL ALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol (70% 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

  • flammable, keep away from fire or flame
  • if taken internally serious gastric disturbances will result

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep 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
  • do not use otherwise than directed

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 (1-800-222-1222) immediately.

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 ingredients

INACTIVE INGREDIENT SECTION

purified water

DISTRIBUTED BY:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Made in USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70% Isopropyl Alcohol
First Aid Antiseptic
Helps prevent the risk of infection in minor, cuts, scrapes and burns.
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY FOIL UNDER THE CAP IS BROKEN OR MISSING.

Principal Display Panel 70% Isopropyl Alcohol First Aid Antiseptic Helps prevent the risk of infection in minor, cuts, scrapes and burns. FL OZ (mL) TAMPER EVIDENT: DO NOT USE I...Principal Display Panel 70% Isopropyl Alcohol First Aid Antiseptic Helps prevent the risk of infection in minor, cuts, scrapes and burns. FL OZ (mL) TAMPER EVIDENT: DO NOT USE I...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN1
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD1
808520isopropyl alcohol 70 % 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
10135-106-082020-01-31C16284748780-19d75b9d0-2131-f424-e053-dadaa90a57ceIsopropyl Alcohol 70 Percent
10135-106-182020-01-31C16284748780-19d75b9d0-2131-f424-e053-dadaa90a57ceIsopropyl Alcohol 70 Percent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-106-08Isopropyl Alcohol 70 Percent473 mL in 1 BOTTLE, PLASTICLIQUID4731
10135-106-18Isopropyl Alcohol 70 Percent3785 mL in 1 BOTTLE, PLASTICLIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-106ISOPROPYL ALCOHOL 70 PERCENT (ISOPROPYL ALCOHOL) LIQUID [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 2 package rows20150902_0cd5ad3d-338e-4df5-892f-8f904687634a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-106-08ML - Milliliter10135-106f8f63883-134b-49a9-a227-f8ed6bb9827d12015-09-10
10135-106-18ML - Milliliter10135-1069933fcb1-4f0a-42f1-acbd-e0d71f3102d912015-09-10

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
10135-10610135-106-08, 10135-106-18

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
33298615-aa50-40d5-8be9-9ba7db16e0b80cd5ad3d-338e-4df5-892f-8f904687634a2015-08-01WarningsExact identifier
spl id: 33298615-aa50-40d5-8be9-9ba7db16e0b8
spl set id: 0cd5ad3d-338e-4df5-892f-8f904687634a

Reported adverse events (FAERS/openFDA)#

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