Alcohol

Manufacturer
Ignacio Reyes Gonzalez
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:44

Label at a glance#

ProductAlcohol
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Clean the affected area, apply small amount of this product 1 to 3 times daily. May be covered with a sterile bandaged, let dry first.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a Isorpopyl Alcohol manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The Isopropyl Alcohol is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (USP or Food Chemical Codex (FCC) grade) (96%, volume/volume (v/v)) in an liquid solution denatured

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 96% v/v. Purpose: First aid Antiseptic

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

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 - DO NOT USE SECTION

  • do not use with electricautery procedures

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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 the affected area, apply small amount of this product 1 to 3 times daily.
  • May be covered with a sterile bandaged, let dry first.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Purified Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473473743 mL NDC: 77196-004-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77196-004-012022-01-28C16284748780-1d6a99b39-7d6e-a426-e053-dadaa90af4c2b1bddac3-3b72-7cbe-e053-2995a90a0ba8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77196-004-01Alcohol473.17 mL in 1 BOTTLE, PLASTICLIQUID473.171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77196-004ALCOHOL LIQUID [IGNACIO REYES GONZALEZ]1Legacy NDC, 1 package rows20201016_b1bddac3-3b72-7cbe-e053-2995a90a0ba8.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77196-00477196-004-01

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
ALCOHOL3K9958V90MACTIB
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
a7bf15e7-0bd9-6a01-e053-2995a90a69abb1bddac3-3b72-7cbe-e053-2995a90a0ba82020-06-10WarningsExact identifier
spl id: a7bf15e7-0bd9-6a01-e053-2995a90a69ab
spl set id: b1bddac3-3b72-7cbe-e053-2995a90a0ba8

Reported adverse events (FAERS/openFDA)#

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