FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
Fortress Expert Co., Ltd
Effective date
2020-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:56

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Helps reduce bacteria that potentially can cause disease Helps prevent cross contamination on contact Recommended for repeated use

Dosage and administration

Wet hands thoroughly with product and rub completely covering hands ·Allow to dry without wiping ·Children under the age of 6 should use with adult supervision Not recommended for infants

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75%v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Helps reduce bacteria that potentially can cause disease

Helps prevent cross contamination on contact

Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

·Flammable,Keep away from fire or flame

·Do not use near eyes

·In case of eye contact flush with water for 15 minutes

·If irritation persists stop use of product and get medical attention

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion seek medical attention or

contact a poison control center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and rub completely

covering hands

·Allow to dry without wiping

·Children under the age of 6 should use with adult

supervision

Not recommended for infants

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(Aqua) ,Acrylates/C10-30 Alkyl Acrylate Grosspolymer,Aminomethyl Propanol.

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50ml 60ml 100ml label50ml 60ml 100ml label250ml 300ml 480ml label250ml 300ml 480ml label500ml 750ml 946.35ml label500ml 750ml 946.35ml label950ml 2000ml 3785.4ml label950ml 2000ml 3785.4ml label30 ml label30 ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73549-006-012022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-022022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-032022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-042022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-052022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-062022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-072022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-082022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-092022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-102022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-112022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-122022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER
73549-006-132022-01-28C16284748780-1d6a99b39-8f35-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73549-006-01HAND SANITIZER30 mL in 1 BOTTLEGEL301
73549-006-02HAND SANITIZER50 mL in 1 BOTTLEGEL501
73549-006-03HAND SANITIZER60 mL in 1 BOTTLEGEL601
73549-006-04HAND SANITIZER100 mL in 1 BOTTLEGEL1001
73549-006-05HAND SANITIZER250 mL in 1 BOTTLEGEL2501
73549-006-06HAND SANITIZER300 mL in 1 BOTTLEGEL3001
73549-006-07HAND SANITIZER480 mL in 1 BOTTLEGEL4801
73549-006-08HAND SANITIZER500 mL in 1 BOTTLEGEL5001
73549-006-09HAND SANITIZER750 mL in 1 BOTTLEGEL7501
73549-006-10HAND SANITIZER946.35 mL in 1 BOTTLEGEL946.351
73549-006-11HAND SANITIZER950 mL in 1 BOTTLEGEL9501
73549-006-12HAND SANITIZER2000 mL in 1 BOTTLEGEL20001
73549-006-13HAND SANITIZER3785.4 mL in 1 BOTTLEGEL3785.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73549-006HAND SANITIZER GEL [FORTRESS EXPERT CO., LTD]1Legacy NDC, 13 package rows20200625_a8cf0f99-06ec-2d1b-e053-2a95a90ad4f9.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
73549-00673549-006-01, 73549-006-02, 73549-006-03, 73549-006-04, 73549-006-05, 73549-006-06, 73549-006-07, 73549-006-08, 73549-006-09, 73549-006-10, 73549-006-11, 73549-006-12, 73549-006-13

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
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
a8cf19af-fbff-c102-e053-2a95a90a35afa8cf0f99-06ec-2d1b-e053-2a95a90ad4f92020-06-24WarningsExact identifier
spl id: a8cf19af-fbff-c102-e053-2a95a90a35af
spl set id: a8cf0f99-06ec-2d1b-e053-2a95a90ad4f9

Reported adverse events (FAERS/openFDA)#

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