FDA.reportPublic FDA data

SCENTED ANTI-BACTERIAL HAND SANITIZERS

Manufacturer
Fortress Expert Co., Ltd
Effective date
2021-05-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:31

Label at a glance#

ProductSCENTED ANTI-BACTERIAL HAND SANITIZERS
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

■ Rub dime sized amount between hands until dry. ■ Supervise children in the use of this product. ■ In the case of eye contact, rinse eyes thoroughly with water.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 63%.....Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

■ For handwashing to decrease bacteria on the skin ■ Recommended for repeated use

Warnings

WARNINGS SECTION

■ For external use only

■ Flammable, keep away from open flame and sources of heat

■ Does not contain grain alcohol; do not drink. If taken internally will produce gastric distrubances.

When using this product

OTC - WHEN USING SECTION

■ Avoid the eyes and mucoous membranes

■ In the case of eyes or mucous membranes contacr, rinse area thoroughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

■Redness or irritation develops
■Conditions worsens
■If condition persists for more than 3 days.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

■ If swallowed, contact a doctor or Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

■ Rub dime sized amount between hands until dry.

■ Supervise children in the use of this product.

■ In the case of eye contact, rinse eyes thoroughly with water.

Other information

SPL UNCLASSIFIED SECTION

■ Store below 105ºF

■ May discolor some fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Wate(Aqua), Acryates/C10-30 Akyl Acryae Crosspolymer, Aminomethyl Propanol, PEG-40 Hydrogenated Castor OiL, Fragrance(Parfum) .

Questions?

OTC - QUESTIONS SECTION

■ 1-844-884-4910

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

73549-014-01 XZ21E100 30ML 73549-014-01 XZ21E100 30ML73549-014-01 XZ21E100 30ML

73549-014-02 XZ21E100 90ML

73549-014-02 XZ21E100 90ML73549-014-02 XZ21E100 90ML

73549-014-03 XZ21E101 30ML

73549-014-03 XZ21E101 30ML73549-014-03 XZ21E101 30ML

73549-014-04 XZ21E101 90ML

73549-014-04 XZ21E101 90ML73549-014-04 XZ21E101 90ML

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094724ethanol 63 % Topical GelPSN1
1094724ethanol 0.63 ML/ML Topical GelSCD1
1094724ethanol 63 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73549-014-012022-07-29C16284748780-1e4f33bdf-a4a3-d8a0-e053-dadaa90a6e4e73549-014 SCENTED ANTI-BACTERIAL HAND SANITIZERS
73549-014-022022-07-29C16284748780-1e4f33bdf-a4a3-d8a0-e053-dadaa90a6e4e73549-014 SCENTED ANTI-BACTERIAL HAND SANITIZERS
73549-014-032022-07-29C16284748780-1e4f33bdf-a4a3-d8a0-e053-dadaa90a6e4e73549-014 SCENTED ANTI-BACTERIAL HAND SANITIZERS
73549-014-042022-07-29C16284748780-1e4f33bdf-a4a3-d8a0-e053-dadaa90a6e4e73549-014 SCENTED ANTI-BACTERIAL HAND SANITIZERS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73549-014-01SCENTED ANTI-BACTERIAL HAND SANITIZERS30 mL in 1 BOTTLEGEL301
73549-014-02SCENTED ANTI-BACTERIAL HAND SANITIZERS90 mL in 1 BOTTLEGEL901
73549-014-03SCENTED ANTI-BACTERIAL HAND SANITIZERS30 mL in 1 BOTTLEGEL301
73549-014-04SCENTED ANTI-BACTERIAL HAND SANITIZERS90 mL in 1 BOTTLEGEL901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73549-014SCENTED ANTI-BACTERIAL HAND SANITIZERS GEL [FORTRESS EXPERT CO., LTD]1Legacy NDC, 4 package rows20210525_c30a03d2-5341-d62b-e053-2a95a90adbd5.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
73549-01473549-014-01, 73549-014-02, 73549-014-03, 73549-014-04

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
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT

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
c30a023c-74bf-44b3-e053-2995a90ab1b4c30a03d2-5341-d62b-e053-2a95a90adbd52021-05-23WarningsExact identifier
spl id: c30a023c-74bf-44b3-e053-2995a90ab1b4
spl set id: c30a03d2-5341-d62b-e053-2a95a90adbd5

Reported adverse events (FAERS/openFDA)#

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