FDA.reportPublic FDA data

Gel Hand Sanitizer

Manufacturer
Marquis Extraction Technology LLC
Effective date
2020-06-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:36

Label at a glance#

ProductGel Hand 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 0% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin 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
  • in eyes

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

acrylates copolymer, alpha-tocopherol acetate, detaonium benzoate, glycerin, isopropyl myristate, Propylene glycol, Tert-butyl alcohol, triisopropylamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76585-003-20NDC 76585-003-20

59 mL NDC: 76585-003-20

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
76585-003-112022-01-28C16284748780-1d6a99b39-a98f-a426-e053-dadaa90af4c2a7a7e50d-ee52-3e44-e053-2a95a90a6803
76585-003-122022-01-28C16284748780-1d6a99b39-a98f-a426-e053-dadaa90af4c2a7a7e50d-ee52-3e44-e053-2a95a90a6803
76585-003-132022-01-28C16284748780-1d6a99b39-a98f-a426-e053-dadaa90af4c2a7a7e50d-ee52-3e44-e053-2a95a90a6803
76585-003-142022-01-28C16284748780-1d6a99b39-a98f-a426-e053-dadaa90af4c2a7a7e50d-ee52-3e44-e053-2a95a90a6803
76585-003-152022-01-28C16284748780-1d6a99b39-a98f-a426-e053-dadaa90af4c2a7a7e50d-ee52-3e44-e053-2a95a90a6803
76585-003-162022-01-28C16284748780-1d6a99b39-a98f-a426-e053-dadaa90af4c2a7a7e50d-ee52-3e44-e053-2a95a90a6803
76585-003-172022-01-28C16284748780-1d6a99b39-a98f-a426-e053-dadaa90af4c2a7a7e50d-ee52-3e44-e053-2a95a90a6803
76585-003-182022-01-28C16284748780-1d6a99b39-a98f-a426-e053-dadaa90af4c2a7a7e50d-ee52-3e44-e053-2a95a90a6803
76585-003-202022-01-28C16284748780-1d6a99b39-a98f-a426-e053-dadaa90af4c2a7a7e50d-ee52-3e44-e053-2a95a90a6803

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76585-003-11Gel Hand Sanitizer473 mL in 1 BOTTLEGEL4732
76585-003-12Gel Hand Sanitizer1040875 mL in 1 BOTTLEGEL10408752
76585-003-13Gel Hand Sanitizer236 mL in 1 BOTTLEGEL2362
76585-003-14Gel Hand Sanitizer946 mL in 1 BOTTLEGEL9462
76585-003-15Gel Hand Sanitizer12113 mL in 1 BOTTLEGEL121132
76585-003-16Gel Hand Sanitizer18927 mL in 1 BOTTLEGEL189272
76585-003-17Gel Hand Sanitizer3785 mL in 1 BOTTLEGEL37852
76585-003-18Gel Hand Sanitizer355 mL in 1 BOTTLEGEL3552
76585-003-20Gel Hand Sanitizer59 mL in 1 BOTTLEGEL592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76585-003GEL HAND SANITIZER GEL [MARQUIS EXTRACTION TECHNOLOGY LLC]2Legacy NDC, 9 package rows20200614_a7a7e50d-ee52-3e44-e053-2a95a90a6803.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76585-00376585-003-20, 76585-003-16, 76585-003-18, 76585-003-12, 76585-003-15, 76585-003-14, 76585-003-13, 76585-003-11, 76585-003-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TRIISOPROPYLAMINEY67CF9Z56LIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT

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
a7fcbcc2-5313-4d41-e053-2a95a90a38e2a7a7e50d-ee52-3e44-e053-2a95a90a68032020-06-13WarningsExact identifier
spl id: a7fcbcc2-5313-4d41-e053-2a95a90a38e2
spl set id: a7a7e50d-ee52-3e44-e053-2a95a90a6803

Reported adverse events (FAERS/openFDA)#

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