FDA.reportPublic FDA data

E-Z Hand Sanitizer - Liquid

Manufacturer
Easy Energy Systems, Inc.
Effective date
2021-07-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:41:35

Label at a glance#

Product80% with Denaturant and Fragrance
Active ingredientALCOHOL
Label structure14 sections

Indications and uses

Hand Sanitizer helps reduce germs on the skin that may cause disease.

Dosage and administration

Apply a palmful of the product in cupped hand, covering all surfaces well with product. Rub hands together for 15 seconds, pay attention between fingers, fingernails and cuticles. Allow to dry without wiping. Prevent swallowing. Supervise children less than 6 years old.

Storage and handling

Store between 59° F and 86° F Avoid freezing and high heat (above 104° F)

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.
  5. Denaturant
  6. Fragrance

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer helps reduce germs on the skin that may cause disease.

Warnings

WARNINGS SECTION

Flammable. Not for Human Consumption

• External Use Only

• Keep away from heat or flame

OTC - DO NOT USE SECTION

  • Do not use with children less than 2 months old
  • Do not use on open skin wounds

OTC - WHEN USING SECTION

If contact with eyes, rinse thoroughly with clean water.

OTC - STOP USE SECTION

Stop use if irritation or rash appear.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, Call Poison Control Center: 800 - 222 - 1222

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a palmful of the product in cupped hand, covering all surfaces well with product.

Rub hands together for 15 seconds, pay attention between fingers, fingernails and cuticles.

Allow to dry without wiping.

Prevent swallowing.

Supervise children less than 6 years old.

Other information

STORAGE AND HANDLING SECTION

  • Store between 59° F and 86° F
  • Avoid freezing and high heat (above 104° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

bitrex, distilled water, fragrance, glycerin, hydrogen peroxide

RECENT MAJOR CHANGES SECTION

We are adding a different product (81184-005-05), so this is the new label for that new product.

It is not a revision of the old product (81184-003-03) at all.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 ml image for 81184-005-053785 ml image for 81184-005-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN4
1039339ethanol 0.8 ML/ML Topical SolutionSCD4
1039339ethanol 80 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81184-005-032023-01-30C16284748780-1f386c649-c2dc-0266-e053-dadaa90a7c1ab45619b4-56b0-2ae6-e053-2a95a90afea4
81184-005-052023-01-30C16284748780-1f386c649-c2dc-0266-e053-dadaa90a7c1ab45619b4-56b0-2ae6-e053-2a95a90afea4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81184-005-0380% with Denaturant and Fragrance118 mL in 1 BOTTLELIQUID1184
81184-005-0580% with Denaturant and Fragrance3785 mL in 1 BOTTLELIQUID37854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81184-00580% WITH DENATURANT AND FRAGRANCE (EASY ECOSAVE) LIQUID [EASY ENERGY SYSTEMS, INC.]4Legacy NDC, 2 package rows20210720_b45619b4-56b0-2ae6-e053-2a95a90afea4.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81184-00581184-005-05, 81184-005-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
COUMARINA4VZ22K1WTIACT
GLYCEROL FORMAL3L7GR2604EIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
DENATONIUM BENZOATE ANHYDROUSM5BA6GAF1OIACT
ALCOHOL3K9958V90MACTIB

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
c7845125-af05-1386-e053-2a95a90a92d8b45619b4-56b0-2ae6-e053-2a95a90afea42021-07-19WarningsExact identifier
spl id: c7845125-af05-1386-e053-2a95a90a92d8
spl set id: b45619b4-56b0-2ae6-e053-2a95a90afea4

Reported adverse events (FAERS/openFDA)#

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