FDA.reportPublic FDA data

Alcohol Isopropilico

Manufacturer
PENSEUR PRODUCTS GROUP LLC
Effective date
2020-08-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:35

Label at a glance#

ProductAlcohol Isopropilico
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

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

Storage and handling

Store at room temperature Does not contain, nor is intended as a substitute for grain or ethyl alcohol

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

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 heat or flame

Do not use

OTC - ASK DOCTOR SECTION

  • if you have deep or puncture wounds, animal bites, or serious burns.

OTC - WHEN USING SECTION

When using this product 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 condition persists or gets worse.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 ml NDC: 79878-004-00

118 ML Label118 ML Label237 ml NDC: 79878-004-01

237 ML Label 2237 ML Label 2473 ml NDC: 79878-004-02

473 ML Label473 ML Label946 ml NDC: 79878-004-03

946 ML Label946 ML Label3785 ml NDC: 79878-004-04

3785 ML Label 23785 ML Label 2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79878-004-002022-01-28C16284748780-1d6a99b39-e161-a426-e053-dadaa90af4c2ad8aa494-8b74-df4f-e053-2995a90a3119
79878-004-012022-01-28C16284748780-1d6a99b39-e161-a426-e053-dadaa90af4c2ad8aa494-8b74-df4f-e053-2995a90a3119
79878-004-022022-01-28C16284748780-1d6a99b39-e161-a426-e053-dadaa90af4c2ad8aa494-8b74-df4f-e053-2995a90a3119
79878-004-032022-01-28C16284748780-1d6a99b39-e161-a426-e053-dadaa90af4c2ad8aa494-8b74-df4f-e053-2995a90a3119
79878-004-042022-01-28C16284748780-1d6a99b39-e161-a426-e053-dadaa90af4c2ad8aa494-8b74-df4f-e053-2995a90a3119

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79878-004-00Alcohol Isopropilico118 mL in 1 BOTTLELIQUID1181
79878-004-01Alcohol Isopropilico237 mL in 1 BOTTLELIQUID2371
79878-004-02Alcohol Isopropilico473 mL in 1 BOTTLELIQUID4731
79878-004-03Alcohol Isopropilico946 mL in 1 BOTTLELIQUID9461
79878-004-04Alcohol Isopropilico3785 mL in 1 BOTTLELIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79878-004ALCOHOL ISOPROPILICO (ISOPROPYL ALCOHOL) LIQUID [PENSEUR PRODUCTS GROUP LLC]1Legacy NDC, 5 package rows20200824_ad8aa494-8b74-df4f-e053-2995a90a3119.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79878-00479878-004-00, 79878-004-01, 79878-004-02, 79878-004-03, 79878-004-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
ad8aa494-8b66-df4f-e053-2995a90a3119ad8aa494-8b74-df4f-e053-2995a90a31192020-08-23WarningsExact identifier
spl id: ad8aa494-8b66-df4f-e053-2995a90a3119
spl set id: ad8aa494-8b74-df4f-e053-2995a90a3119

Reported adverse events (FAERS/openFDA)#

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