FDA.reportPublic FDA data

EMHS1 Hand Sanitizer

Manufacturer
Sayida Group LLC
Effective date
2020-06-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:59

Label at a glance#

ProductEMHS1 Hand Sanitizer
Active ingredientALCOHOL
Label structure12 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

Do not store above 43C (110F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria that can potentially cause disease.

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

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

Do not store above 43C (110F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Isopropyl alcohol, Quaternary ammonium, Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISTRIBUTED BY: Sayida Group

6538 Collins Ave #401

Miami Beach, FL 33141

EMHS1 Hand Sanitizer (bottle, pump - 1L) NDC: 77858-0754-1

EMHS1 Hand Sanitizer (bottle - 1L) NDC: 77858-0754-2

LiterLiter

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77858-0754-12022-01-28C16284748780-1d6a99b39-8edb-a426-e053-dadaa90af4c2EMHS1 Hand Sanitizer (gel - 1L) bottle, pump NDC: 77858-0754-1 EMHS1 Hand Sanitizer (gel - 1L) bottle NDC: 77858-0754-2
77858-0754-22022-01-28C16284748780-1d6a99b39-8edb-a426-e053-dadaa90af4c2EMHS1 Hand Sanitizer (gel - 1L) bottle, pump NDC: 77858-0754-1 EMHS1 Hand Sanitizer (gel - 1L) bottle NDC: 77858-0754-2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77858-0754-1EMHS1 Hand Sanitizer1 L in 1 BOTTLE, PUMPGEL12
77858-0754-2EMHS1 Hand Sanitizer1 L in 1 BOTTLEGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77858-0754EMHS1 HAND SANITIZER (ALCOHOL) GEL [SAYIDA GROUP LLC]2Legacy NDC, 2 package rows20200617_a839cd17-cb5f-6898-e053-2995a90aba06.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77858-075477858-0754-1, 77858-0754-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
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
a839e6df-7009-8e6a-e053-2995a90a7536a839cd17-cb5f-6898-e053-2995a90aba062020-06-16WarningsExact identifier
spl id: a839e6df-7009-8e6a-e053-2995a90a7536
spl set id: a839cd17-cb5f-6898-e053-2995a90aba06

Reported adverse events (FAERS/openFDA)#

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