FDA.reportPublic FDA data

Genuine First Aid Hand Sanitizer Ethyl Alcohol

Manufacturer
GFA Production (Xiamen) Co., Ltd.
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:25:49

Label at a glance#

ProductGenuine First Aid Hand Sanitizer Ethyl Alcohol
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

For hand washing to decrease bacteria on the skin that may cause disease. Recommended for repeated use. 

Dosage and administration

Wet hands thoroughly with product and allow todry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For hand washing to decrease bacteria on the skin that may cause disease.
  • Recommended for repeated use. 

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame 

For external use only.

Intended for use exclusively by adults.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

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

  • Wet hands thoroughly with product and allow todry without wiping.

Other information

SPL UNCLASSIFIED SECTION

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylic acid Polymers, Propylene glycol, Trolamine, Purified water.

Package Labeling:473ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:946ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle7Bottle7

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50814-063-01Genuine First Aid Hand Sanitizer Ethyl Alcohol473 mL in 1 BOTTLEGEL4733
50814-063-02Genuine First Aid Hand Sanitizer Ethyl Alcohol946 mL in 1 BOTTLEGEL9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-063GENUINE FIRST AID HAND SANITIZER ETHYL ALCOHOL (ALCOHOL) GEL [GFA PRODUCTION (XIAMEN) CO., LTD.]3Current NDC, Legacy NDC, 2 package rows20241017_af8466d7-794a-cb95-e053-2a95a90a6ffc.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
50814-06350814-063-01, 50814-063-02

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
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
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
Genuine First Aid Hand Sanitizer Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af8466d7-794a-cb95-e053-2a95a90a6ffc2024-10-15WarningsExact identifier
ndc (package): 50814-063-02
ndc (package): 50814-063-01
ndc (product): 50814-063
ndc11 (package): 50814006301
ndc11 (package): 50814006302
spl id: 247f0f72-f854-6b93-e063-6394a90a84f7
spl set id: af8466d7-794a-cb95-e053-2a95a90a6ffc

Reported adverse events (FAERS/openFDA)#

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