FDA.reportPublic FDA data

Germs be gone hand Sanitizer

Manufacturer
Brands International
Effective date
2021-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:29

Label at a glance#

ProductGerms be gone hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

instant hand antiseptic to decrease bacteria on the skin

Dosage and administration

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry. Supervise children in the use of this product.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol, 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • instant hand antiseptic to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if significant irritation or sensitization develops.

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

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

  • Supervise children in the use of this product.

Other Information

SPL UNCLASSIFIED SECTION

Store below 43°C (110°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer, aloe barbadensis leaf juice, aminomethyl propanol, disodium EDTA, glycerin, PEG-40, propylene glycol, water, isopropyl myristate, tocopheryl acetate (Vit E)., isopropyl alcohol

Please see label on the container.

OTC - QUESTIONS SECTION

1-866-234-2345

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118118

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473473

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

378378

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN2
1047755ethanol 0.75 ML/ML Topical SolutionSCD2
1047755ethanol 75 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-507-142025-01-30C16284748780-12cef2736-6ae3-d83d-e063-dadaa90ab31fGerms Be Gone Hand sanitizer
50157-507-182025-01-30C16284748780-12cef2736-6ae3-d83d-e063-dadaa90ab31fGerms Be Gone Hand sanitizer
50157-507-382025-01-30C16284748780-12cef2736-6ae3-d83d-e063-dadaa90ab31fGerms Be Gone Hand sanitizer
50157-507-472025-01-30C16284748780-12cef2736-6ae3-d83d-e063-dadaa90ab31fGerms Be Gone Hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-507-14Germs be gone hand Sanitizer148 mL in 1 BOTTLELIQUID1482
50157-507-18Germs be gone hand Sanitizer118 mL in 1 BOTTLELIQUID1182
50157-507-38Germs be gone hand Sanitizer3780 mL in 1 BOTTLELIQUID37802
50157-507-47Germs be gone hand Sanitizer473 mL in 1 BOTTLELIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-507GERMS BE GONE HAND SANITIZER (ALCOHOL) LIQUID [BRANDS INTERNATIONAL]2Legacy NDC, 4 package rows20210408_57fcdb22-adf1-4ab4-85e1-6e98d376d8c6.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-50750157-507-18, 50157-507-47, 50157-507-38, 50157-507-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
EDETATE DISODIUM7FLD91C86KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
bf6d63b6-cf0b-e04a-e053-2a95a90a9f8b57fcdb22-adf1-4ab4-85e1-6e98d376d8c62021-04-07WarningsExact identifier
spl id: bf6d63b6-cf0b-e04a-e053-2a95a90a9f8b
spl set id: 57fcdb22-adf1-4ab4-85e1-6e98d376d8c6

Reported adverse events (FAERS/openFDA)#

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