FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
Fortress Expert Co., Ltd
Effective date
2020-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:33

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure11 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

Storage and handling

Store below 105F(41C) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 62%

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

Flammable, keep away from open flame and sources of heat

External use only

Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

Keep out of reach of children

OTC - DO NOT USE SECTION

Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, call a poison control center or get medical help right away .

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

Other information

STORAGE AND HANDLING SECTION

Store below 105F(41C)

May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Acrylates/C10- Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance

PEG-40 Hydrogenated Castor Oil. May man FD&C RED NO 4( 14700), D& REN0.33(C 17200), FD&C YELLOW NO 5(C 19140), FD&C BLUE NO. 1(CI 42090)

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11223344

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73549-008-012022-01-28C16284748780-1d6a99b39-910c-a426-e053-dadaa90af4c2008 HAND SANITIZER
73549-008-022022-01-28C16284748780-1d6a99b39-910c-a426-e053-dadaa90af4c2008 HAND SANITIZER
73549-008-032022-01-28C16284748780-1d6a99b39-910c-a426-e053-dadaa90af4c2008 HAND SANITIZER
73549-008-042022-01-28C16284748780-1d6a99b39-910c-a426-e053-dadaa90af4c2008 HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73549-008-01HAND SANITIZER30 mL in 1 BOTTLEGEL301
73549-008-02HAND SANITIZER60 mL in 1 BOTTLEGEL601
73549-008-03HAND SANITIZER237 mL in 1 BOTTLEGEL2371
73549-008-04HAND SANITIZER1800 mL in 1 BOTTLEGEL18001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73549-008HAND SANITIZER GEL [FORTRESS EXPERT CO., LTD]1Legacy NDC, 4 package rows20200725_ab1d8069-2c4e-056c-e053-2a95a90acf2e.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73549-00873549-008-01, 73549-008-02, 73549-008-03, 73549-008-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 4X3W0AM1JLXIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
ab1d8069-2c4f-056c-e053-2a95a90acf2eab1d8069-2c4e-056c-e053-2a95a90acf2e2020-07-23WarningsExact identifier
spl id: ab1d8069-2c4f-056c-e053-2a95a90acf2e
spl set id: ab1d8069-2c4e-056c-e053-2a95a90acf2e

Reported adverse events (FAERS/openFDA)#

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