FDA.reportPublic FDA data

EMU Hand Sanitizer Mist Mint

Manufacturer
Everyone Must Use, LLC
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:25

Label at a glance#

ProductEMU Hand Sanitizer Mist Mint
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise childrenunder 6 years of age to avoid swallowing.

Storage and handling

Store between 15°-30° C (59°-86°F)

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Drug Facts

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.

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose
Ethyl Alcohol 62%Antiseptic

Uses

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. | Contents under pressure.

Do not use

OTC - DO NOT USE SECTION

on children less than 2 months of age. Do not use 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.

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 childrenunder 6 years of age to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

Store between 15°-30° C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Purified Water, Tocopheryl Acetate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-250-4643

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Net Wt 2.2 FL OZ (62.4g) NDC: 80464-1004-1

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020364ethanol 62 % Topical SprayPSN3
1020364ethanol 0.62 ML/ML Topical SpraySCD3
1020364ethanol 62 % Topical SpraySY3
1020364ethyl alcohol 62 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80464-1004-12024-07-30C16284748780-10191ceaa-66aa-198a-e063-dbdaa90aec3eEMU Hand Sanitizer Mist Mint
80464-1004-12023-12-22C16284748780-10191ceaa-66aa-198a-e063-dbdaa90aec3eEMU Hand Sanitizer Mist Mint
80464-1004-12023-07-28C16284748780-10191ceaa-66aa-198a-e063-dbdaa90aec3eEMU Hand Sanitizer Mist Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80464-1004-1EMU Hand Sanitizer Mist Mint62.4 g in 1 BOTTLE, SPRAYSPRAY62.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80464-1004EMU HAND SANITIZER MIST MINT (ALCOHOL) SPRAY [EVERYONE MUST USE, LLC]3Legacy NDC, 1 package rows20231222_b4fed0ad-21a0-66e8-e053-2995a90ab9bc.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
80464-100480464-1004-1

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
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
0d13915c-7bdf-6c9b-e063-6294a90acd6eb4fed0ad-21a0-66e8-e053-2995a90ab9bc2023-12-22WarningsExact identifier
spl id: 0d13915c-7bdf-6c9b-e063-6294a90acd6e
spl set id: b4fed0ad-21a0-66e8-e053-2995a90ab9bc

Reported adverse events (FAERS/openFDA)#

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