Heroes Alcohol Antiseptic 80% Topical Solution

Manufacturer
Gold Eagle Co.
Effective date
2020-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:12

Label at a glance#

ProductHeroes Alcohol Antiseptic 80% Topical Solution
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

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

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

  • on children less than 2 months of age
  • on open skin wounds

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

Glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

Antiseptic Hand Rub Non-Sterile Solution

DO NOT AIR SHIP

©2020 Gold Eagle Co.

Gold Eagle Co.

4400 S. Kildare

Chicago, IL 60632

(800) 367-3245

goldeagle.com

MADE IN USA

21006 4.2020

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HeronwHeronw

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78007-111-12Heroes Alcohol Antiseptic 80% Topical Solution355 mL in 1 BOTTLESOLUTION3551
78007-111-16Heroes Alcohol Antiseptic 80% Topical Solution473 mL in 1 BOTTLESOLUTION4731
78007-111-28Heroes Alcohol Antiseptic 80% Topical Solution3785 mL in 1 BOTTLESOLUTION37851
78007-111-32Heroes Alcohol Antiseptic 80% Topical Solution946 mL in 1 BOTTLESOLUTION9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78007-111HEROES ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION (ALCOHOL) SOLUTION [GOLD EAGLE CO.]1Legacy NDC, 4 package rows20200605_aff1ef63-be5f-4d48-9acb-fd9490452165.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
78007-11178007-111-12, 78007-111-16, 78007-111-32, 78007-111-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
0644803f-ffe1-4eac-a8ad-6e6d5a03f26daff1ef63-be5f-4d48-9acb-fd94904521652020-05-21WarningsExact identifier
spl id: 0644803f-ffe1-4eac-a8ad-6e6d5a03f26d
spl set id: aff1ef63-be5f-4d48-9acb-fd9490452165

Reported adverse events (FAERS/openFDA)#

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