FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Flamingo Paper & Food Services Products, Corp | ELEMENT PACKAGING LLC | ELEMENT PACKAGING, LLC
Effective date
2020-09-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:12

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store below 110F (43C) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from heat or flame.For external use only.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • Put enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F (43C)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua, Glycerin, Carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80451-003-01_Label80451-003-01_Label2mL NDC: 80451-003-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80451-003-012022-01-28C16284748780-1d6a99b39-b0d2-a426-e053-dadaa90af4c2Protekto Hand Sanitizer Infused with Aloe Vera

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80451-003-01Hand Sanitizer2 mL in 1 CELLO PACKGEL21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80451-003HAND SANITIZER (ALCOHOL) GEL [FLAMINGO PAPER & FOOD SERVICES PRODUCTS, CORP]1Legacy NDC, 1 package rows20200925_af9e4bd3-4320-d0de-e053-2a95a90a7ed6.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
80451-00380451-003-01

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
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
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
af9d681a-8854-3c58-e053-2a95a90a8c93af9e4bd3-4320-d0de-e053-2a95a90a7ed62020-09-18WarningsExact identifier
spl id: af9d681a-8854-3c58-e053-2a95a90a8c93
spl set id: af9e4bd3-4320-d0de-e053-2a95a90a7ed6

Reported adverse events (FAERS/openFDA)#

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