FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Fortress Expert Co., Ltd
Effective date
2020-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:10:20

Label at a glance#

ProductHand Sanitizer
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

Water, PEG-40 Hydrogenated Castor Oil, Carbomer, Fragrance

(Parfum) , Triethanolamine,Triisopropanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 ml label15 ml label30 ml label30 ml label50 ml label50 ml label59 ml label59 ml label65 ml label65 ml label100 ml label100 ml label120 ml label120 ml label150 ml label150 ml label236 ml label236 ml label250 ml label250 ml label300 ml label300 ml label330 ml label330 ml label480 ml label480 ml label500 ml label500 ml label944 ml label944 ml label950 ml label950 ml label1.8 L label1.8 L label5 L label5 L label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2367754ethanol 75.1 % Topical GelPSN1
2367754ethanol 0.751 ML/ML Topical GelSCD1
2367754ethanol 75.1 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73549-002-012022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-022022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-032022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-042022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-052022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-062022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-072022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-082022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-092022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-102022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-112022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-122022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-132022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-142022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-152022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-162022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-172022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER
73549-002-182022-01-28C16284748780-1d6a99b39-3cc3-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73549-002-01Hand Sanitizer15 mL in 1 BOTTLEGEL151
73549-002-02Hand Sanitizer30 mL in 1 BOTTLEGEL301
73549-002-03Hand Sanitizer50 mL in 1 BOTTLEGEL501
73549-002-04Hand Sanitizer59 mL in 1 BOTTLEGEL591
73549-002-05Hand Sanitizer65 mL in 1 BOTTLEGEL651
73549-002-06Hand Sanitizer100 mL in 1 BOTTLEGEL1001
73549-002-07Hand Sanitizer120 mL in 1 BOTTLEGEL1201
73549-002-08Hand Sanitizer150 mL in 1 BOTTLEGEL1501
73549-002-09Hand Sanitizer236 mL in 1 BOTTLEGEL2361
73549-002-10Hand Sanitizer250 mL in 1 BOTTLEGEL2501
73549-002-11Hand Sanitizer300 mL in 1 BOTTLEGEL3001
73549-002-12Hand Sanitizer330 mL in 1 BOTTLEGEL3301
73549-002-13Hand Sanitizer480 mL in 1 BOTTLEGEL4801
73549-002-14Hand Sanitizer500 mL in 1 BOTTLEGEL5001
73549-002-15Hand Sanitizer944 mL in 1 BOTTLEGEL9441
73549-002-16Hand Sanitizer950 mL in 1 BOTTLEGEL9501
73549-002-17Hand Sanitizer1800 mL in 1 BOTTLEGEL18001
73549-002-18Hand Sanitizer5000 mL in 1 BOTTLEGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73549-002HAND SANITIZER GEL [FORTRESS EXPERT CO., LTD]1Legacy NDC, 18 package rows20200509_a4bbba5e-c991-9481-e053-2995a90acefc.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
73549-00273549-002-01, 73549-002-02, 73549-002-03, 73549-002-04, 73549-002-05, 73549-002-06, 73549-002-07, 73549-002-08, 73549-002-09, 73549-002-10, 73549-002-11, 73549-002-12, 73549-002-13, 73549-002-14, 73549-002-15, 73549-002-16, 73549-002-17, 73549-002-18

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
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
TRIISOPROPANOLAMINEW9EN9DLM98IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
a4b7b236-2223-810b-e053-2a95a90ac08ea4bbba5e-c991-9481-e053-2995a90acefc2020-05-03WarningsExact identifier
spl id: a4b7b236-2223-810b-e053-2a95a90ac08e
spl set id: a4bbba5e-c991-9481-e053-2995a90acefc

Reported adverse events (FAERS/openFDA)#

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