FDA.reportPublic FDA data

Alcohol Gel Hand Sanitizer

Manufacturer
Genesis Partnership Company Sociedad Anonima
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:33:44

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

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 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel 500 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ml NDC 74484-002-05 118 ML PACKAGE118 ML PACKAGE500 ml NDC 74484-002-06 500 ML PACKAGE500 ML PACKAGE 1 gallon label1 gallon label NDC: 74484-001-04 450ml label450ml label 240ml label240ml label 55ml label55ml label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74484-002-012022-01-28C16284748780-1d6a99b39-9853-a426-e053-dadaa90af4c2Alcohol Gel Hand Sanitizer
74484-002-022022-01-28C16284748780-1d6a99b39-9853-a426-e053-dadaa90af4c2Alcohol Gel Hand Sanitizer
74484-002-032022-01-28C16284748780-1d6a99b39-9853-a426-e053-dadaa90af4c2Alcohol Gel Hand Sanitizer
74484-002-042022-01-28C16284748780-1d6a99b39-9853-a426-e053-dadaa90af4c2Alcohol Gel Hand Sanitizer
74484-002-052022-01-28C16284748780-1d6a99b39-9853-a426-e053-dadaa90af4c2Alcohol Gel Hand Sanitizer
74484-002-062022-01-28C16284748780-1d6a99b39-9853-a426-e053-dadaa90af4c2Alcohol Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74484-002-01Hand Sanitizer55 mL in 1 BOTTLE, DISPENSINGGEL554
74484-002-02Hand Sanitizer240 mL in 1 BOTTLE, DISPENSINGGEL2404
74484-002-03Hand Sanitizer450 mL in 1 BOTTLE, DISPENSINGGEL4504
74484-002-04Hand Sanitizer3785.41 mL in 1 BOTTLE, DISPENSINGGEL3785.414
74484-002-05Hand Sanitizer118 mL in 1 BOTTLE, DISPENSINGGEL1184
74484-002-06Hand Sanitizer500 mL in 1 BOTTLE, DISPENSINGGEL5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74484-002HAND SANITIZER (ALCOHOL) GEL [GENESIS PARTNERSHIP COMPANY SOCIEDAD ANONIMA]4Legacy NDC, 6 package rows20201117_a31ba71a-138d-98d1-e053-2a95a90a2818.zip

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
74484-00274484-002-01, 74484-002-02, 74484-002-03, 74484-002-04, 74484-002-05, 74484-002-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

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
b43cfcf9-dd17-7b9f-e053-2a95a90a1800a31ba71a-138d-98d1-e053-2a95a90a28182020-11-16WarningsExact identifier
spl id: b43cfcf9-dd17-7b9f-e053-2a95a90a1800
spl set id: a31ba71a-138d-98d1-e053-2a95a90a2818

Reported adverse events (FAERS/openFDA)#

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