FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Marquis Extraction Technology LLC
Effective date
2020-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:57

Label at a glance#

ProductHand 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

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteriaon the skin that potentially can cause disease. For use when soap and water are unavailable

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, Denatonium benzoate, glycerin, isopropyl myristate propylene glycol, triisopropyl amine, fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76585-004NDC 76585-004NDC: 76585-004

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76585-004-112022-01-28C16284748780-1d6a99b39-f6fb-a426-e053-dadaa90af4c2a9560578-0bfb-90a4-e053-2995a90af0cf
76585-004-122022-01-28C16284748780-1d6a99b39-f6fb-a426-e053-dadaa90af4c2a9560578-0bfb-90a4-e053-2995a90af0cf
76585-004-132022-01-28C16284748780-1d6a99b39-f6fb-a426-e053-dadaa90af4c2a9560578-0bfb-90a4-e053-2995a90af0cf
76585-004-142022-01-28C16284748780-1d6a99b39-f6fb-a426-e053-dadaa90af4c2a9560578-0bfb-90a4-e053-2995a90af0cf
76585-004-152022-01-28C16284748780-1d6a99b39-f6fb-a426-e053-dadaa90af4c2a9560578-0bfb-90a4-e053-2995a90af0cf
76585-004-162022-01-28C16284748780-1d6a99b39-f6fb-a426-e053-dadaa90af4c2a9560578-0bfb-90a4-e053-2995a90af0cf
76585-004-172022-01-28C16284748780-1d6a99b39-f6fb-a426-e053-dadaa90af4c2a9560578-0bfb-90a4-e053-2995a90af0cf
76585-004-182022-01-28C16284748780-1d6a99b39-f6fb-a426-e053-dadaa90af4c2a9560578-0bfb-90a4-e053-2995a90af0cf
76585-004-202022-01-28C16284748780-1d6a99b39-f6fb-a426-e053-dadaa90af4c2a9560578-0bfb-90a4-e053-2995a90af0cf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76585-004-11Hand Sanitizer473 mL in 1 BOTTLEGEL4731
76585-004-12Hand Sanitizer1040875 mL in 1 BOTTLEGEL10408751
76585-004-13Hand Sanitizer236 mL in 1 BOTTLEGEL2361
76585-004-14Hand Sanitizer946 mL in 1 BOTTLEGEL9461
76585-004-15Hand Sanitizer12113 mL in 1 BOTTLEGEL121131
76585-004-16Hand Sanitizer18927 mL in 1 BOTTLEGEL189271
76585-004-17Hand Sanitizer3785 mL in 1 BOTTLEGEL37851
76585-004-18Hand Sanitizer355 mL in 1 BOTTLEGEL3551
76585-004-20Hand Sanitizer59 mL in 1 BOTTLEGEL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76585-004HAND SANITIZER (ALCOHOL) GEL [MARQUIS EXTRACTION TECHNOLOGY LLC]1Legacy NDC, 9 package rows20200703_a9560578-0bfb-90a4-e053-2995a90af0cf.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76585-00476585-004-17, 76585-004-11, 76585-004-13, 76585-004-14, 76585-004-12, 76585-004-18, 76585-004-15, 76585-004-16, 76585-004-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
TRIISOPROPYLAMINEY67CF9Z56LIACT
CUMINYL ACETALDEHYDEWSW8QXE6HGIACT
LINALOOL, (+)-F4VNO44C09IACT

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
a955837c-7dbe-f600-e053-2a95a90aca6ba9560578-0bfb-90a4-e053-2995a90af0cf2020-06-30WarningsExact identifier
spl id: a955837c-7dbe-f600-e053-2a95a90aca6b
spl set id: a9560578-0bfb-90a4-e053-2995a90af0cf

Reported adverse events (FAERS/openFDA)#

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