ETHYL ALCOHOL 75%

Manufacturer
ALFA VITAMINS LABORATORIES INC
Effective date
2020-10-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:10:29

Label at a glance#

ProductETHYL ALCOHOL 75%
Active ingredientALCOHOL
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer 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 hand sanitizer 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 (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

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) Ehtyl Alcohol 75% v/v

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

PURPOSEPURPOSE

Use

INDICATIONS & USAGE SECTION

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

indications for useindications for use

Warnings

WARNINGS SECTION

warningswarnings

For external use only. Fammable, keep away from spark, heat and flame

Do not use

OTC - DO NOT USE SECTION

  • When using this product do not get into eyes, do not apply over large areas of the body, do not use longer than 1 week.
  • Do Not UseDo Not Usei

OTC - WHEN USING SECTION

keep outkeep out

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.

KEEP OUT OF REACH OF CHILDRENKEEP OUT OF REACH OF CHILDREN

Directions

DOSAGE & ADMINISTRATION SECTION

directions for usedirections for use

Other information

STORAGE AND HANDLING SECTION

other informationother information

Inactive ingredients

INACTIVE INGREDIENT SECTION

inactive ingredientsinactive ingredients

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC front panelNDC front panel

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13298-25313298-253-16

Ingredients#

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

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

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
ca516dc6-65ac-81d0-e053-2a95a90a660cb21e22a5-77ac-7569-e053-2a95a90acf032021-08-24WarningsExact identifier
spl set id: b21e22a5-77ac-7569-e053-2a95a90acf03

Reported adverse events (FAERS/openFDA)#

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