FDA.reportPublic FDA data

Hand Cleanser

Manufacturer
Fortress Expert Co., Ltd
Effective date
2020-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:13:09

Label at a glance#

ProductHand Cleanser
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

Wet hands thoroughly with product and 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 75.05%

​Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Helps reduce bacteria that potentially can cause disease

Helps prevent cross contamination by hand contact

Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire, heat,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.

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 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

Walen , Glycerin, Carbomer, Hydrogen peroxideAminomethyl Propanol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16161313112233445566779910101111121213131414

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1535597ethanol 76 % Topical GelPSN1
1535597ethanol 0.76 ML/ML Topical GelSCD1
1535597ethanol 76 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73549-003-012022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-022022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-032022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-042022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-052022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-062022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-072022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-082022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-092022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-102022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-112022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-122022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-132022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-142022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-152022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER
73549-003-162022-01-28C16284748780-1d6a99b39-d970-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73549-003-01Hand Cleanser8 mL in 1 BOTTLEGEL81
73549-003-02Hand Cleanser15 mL in 1 BOTTLEGEL151
73549-003-03Hand Cleanser30 mL in 1 BOTTLEGEL301
73549-003-04Hand Cleanser60 mL in 1 BOTTLEGEL601
73549-003-05Hand Cleanser100 mL in 1 BOTTLEGEL1001
73549-003-06Hand Cleanser120 mL in 1 BOTTLEGEL1201
73549-003-07Hand Cleanser150 mL in 1 BOTTLEGEL1501
73549-003-08Hand Cleanser236 mL in 1 BOTTLEGEL2361
73549-003-09Hand Cleanser250 mL in 1 BOTTLEGEL2501
73549-003-10Hand Cleanser300 mL in 1 BOTTLEGEL3001
73549-003-11Hand Cleanser330 mL in 1 BOTTLEGEL3301
73549-003-12Hand Cleanser470 mL in 1 BOTTLEGEL4701
73549-003-13Hand Cleanser500 mL in 1 BOTTLEGEL5001
73549-003-14Hand Cleanser750 mL in 1 BOTTLEGEL7501
73549-003-15Hand Cleanser950 mL in 1 BOTTLEGEL9501
73549-003-16Hand Cleanser5000 mL in 1 BOTTLEGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73549-003HAND CLEANSER GEL [FORTRESS EXPERT CO., LTD]1Legacy NDC, 16 package rows20200515_a59c6933-b760-9883-e053-2995a90af991.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73549-00373549-003-09, 73549-003-02, 73549-003-03, 73549-003-07, 73549-003-08, 73549-003-10, 73549-003-14, 73549-003-04, 73549-003-05, 73549-003-06, 73549-003-15, 73549-003-12, 73549-003-16, 73549-003-01, 73549-003-13, 73549-003-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

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
a59c626f-6ddd-b8bb-e053-2995a90a170fa59c6933-b760-9883-e053-2995a90af9912020-05-14WarningsExact identifier
spl id: a59c626f-6ddd-b8bb-e053-2995a90a170f
spl set id: a59c6933-b760-9883-e053-2995a90af991

Reported adverse events (FAERS/openFDA)#

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