FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Greensys of North America LLC
Effective date
2020-08-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:24:07

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Indications and uses

Health care personnel hand rub to help reduce bacteria that potentially can cause disease. 

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Health care personnel hand rub to help reduce bacteria that potentially can 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

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Glycerin, Triethanolamine, Purified Water USP

Package Labeling: 76692-000-85

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label250Label250

76692-000-86

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

76692-000-87

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

76692-000-88

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

76692-000-89

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76692-000-852021-07-23C16284748780-1c7ccaba7-11a0-fd44-e053-dadaa90aa01bHand Sanitizer
76692-000-862021-07-23C16284748780-1c7ccaba7-11a0-fd44-e053-dadaa90aa01bHand Sanitizer
76692-000-872021-07-23C16284748780-1c7ccaba7-11a0-fd44-e053-dadaa90aa01bHand Sanitizer
76692-000-882021-07-23C16284748780-1c7ccaba7-11a0-fd44-e053-dadaa90aa01bHand Sanitizer
76692-000-892021-07-23C16284748780-1c7ccaba7-11a0-fd44-e053-dadaa90aa01bHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76692-000-85Hand Sanitizer250 mL in 1 BOTTLEGEL2504
76692-000-86Hand Sanitizer60 mL in 1 BOTTLEGEL604
76692-000-87Hand Sanitizer120 mL in 1 BOTTLEGEL1204
76692-000-88Hand Sanitizer500 mL in 1 BOTTLEGEL5004
76692-000-89Hand Sanitizer3785 mL in 1 BOTTLEGEL37854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76692-000HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [GREENSYS OF NORTH AMERICA LLC]4Legacy NDC, 5 package rows20200808_a44bd299-eb10-4e69-e053-2995a90a5ce6.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
76692-00076692-000-85, 76692-000-86, 76692-000-87, 76692-000-88, 76692-000-89

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML · Source PDF

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
ac4c02c2-3552-990e-e053-2a95a90a5483a44bd299-eb10-4e69-e053-2995a90a5ce62020-08-07WarningsExact identifier
spl id: ac4c02c2-3552-990e-e053-2a95a90a5483
spl set id: a44bd299-eb10-4e69-e053-2995a90a5ce6

Reported adverse events (FAERS/openFDA)#

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