FDA.reportPublic FDA data

HEROES Hand Sanitizer Gel

Manufacturer
Gold Eagle Co.
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:34

Label at a glance#

ProductHEROES Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure9 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

Ethanol 72% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

Hand sanitizer 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

• on children less than 2 months of age
• on open skin wounds
• in or near fire
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.

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

Water, Carbomer, Aloe barbadensis leaf, Tocopherol acetate, Siloxane polyalkyleneoxide copolymer, Fragrance, Aminomethyl propanol

SPL UNCLASSIFIED SECTION

Uses Pharmaceutical Grade Alcohol
Refreshing Scent
Keeps Hands Feeling Soft

©2020 Gold Eagle Co.
Gold Eagle Co.
4400 S. Kildare
Chicago, IL 60632
(800) 367-3245
heroeshandsanitizingrub.com

MADE IN USA

DO NOT AIR SHIP

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN1
2277550ethanol 0.72 ML/ML Topical GelSCD1
2277550ethanol 72 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78007-114-152024-01-30C16284748780-11030e365-15f2-111a-e063-dadaa90a10e2HEROES' TM Hand Sanitizer Gel
78007-114-162024-01-30C16284748780-11030e365-15f2-111a-e063-dadaa90a10e2HEROES' TM Hand Sanitizer Gel
78007-114-172024-01-30C16284748780-11030e365-15f2-111a-e063-dadaa90a10e2HEROES' TM Hand Sanitizer Gel
78007-114-182024-01-30C16284748780-11030e365-15f2-111a-e063-dadaa90a10e2HEROES' TM Hand Sanitizer Gel
78007-114-192024-01-30C16284748780-11030e365-15f2-111a-e063-dadaa90a10e2HEROES' TM Hand Sanitizer Gel
78007-114-202024-01-30C16284748780-11030e365-15f2-111a-e063-dadaa90a10e2HEROES' TM Hand Sanitizer Gel
78007-114-212024-01-30C16284748780-11030e365-15f2-111a-e063-dadaa90a10e2HEROES' TM Hand Sanitizer Gel
78007-114-222024-01-30C16284748780-11030e365-15f2-111a-e063-dadaa90a10e2HEROES' TM Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78007-114-15HEROES Hand Sanitizer Gel414 mL in 1 BOTTLE, DISPENSINGGEL4141
78007-114-16HEROES Hand Sanitizer Gel177.4 mL in 1 BOTTLE, DISPENSINGGEL177.41
78007-114-17HEROES Hand Sanitizer Gel177.4 mL in 1 BOTTLE, PUMPGEL177.41
78007-114-18HEROES Hand Sanitizer Gel295.7 mL in 1 BOTTLEGEL295.71
78007-114-19HEROES Hand Sanitizer Gel443.6 mL in 1 BOTTLEGEL443.61
78007-114-20HEROES Hand Sanitizer Gel414 mL in 1 BOTTLEGEL4141
78007-114-21HEROES Hand Sanitizer Gel443.6 mL in 1 BOTTLE, PUMPGEL443.61
78007-114-22HEROES Hand Sanitizer Gel3785 mL in 1 BOTTLE, PUMPGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78007-114HEROES HAND SANITIZER GEL (ALCOHOL) GEL [GOLD EAGLE CO.]1Legacy NDC, 8 package rows20201203_d12b7918-a122-453d-ab17-98d740a916fa.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78007-11478007-114-16, 78007-114-17, 78007-114-18, 78007-114-15, 78007-114-20, 78007-114-19, 78007-114-21, 78007-114-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
ff37228d-0949-4369-90f5-5da4ebfc8e97d12b7918-a122-453d-ab17-98d740a916fa2020-11-16WarningsExact identifier
spl id: ff37228d-0949-4369-90f5-5da4ebfc8e97
spl set id: d12b7918-a122-453d-ab17-98d740a916fa

Reported adverse events (FAERS/openFDA)#

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