FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
Huizhou Maxsee Biological Technology Co.,Ltd.
Effective date
2020-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:49

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Pump amount 3 ml- 5 ml into your palms, and spread thoroughly on both hands inside outside, rub onto skin until dry

Storage and handling

24 months shelf life. Stored in a cool and dry place, avoid direct sunlight or high temperature(below 35 C)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75.0%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin

Warning

WARNINGS SECTION

Flammable, keep away from fire, flame or high temperature

Precautions

OTC - WHEN USING SECTION

For external use only, avoid contact with eves, faces and wounds. If you feel unwell after use, stop using it immediately and consult a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

Pump amount 3 ml- 5 ml into your palms, and spread thoroughly on both hands inside outside, rub onto skin until dry

Other information

STORAGE AND HANDLING SECTION

24 months shelf life. Stored in a cool and dry place, avoid direct sunlight or high temperature(below 35 C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis leaf juice, Carbomer, Triethanolamine Fragrance, Glycerin,

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

all typeall type

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
75389-005-012022-01-28C16284748780-1d6a99b39-3c01-a426-e053-dadaa90af4c2Hand Sanitizer Gel
75389-005-022022-01-28C16284748780-1d6a99b39-3c01-a426-e053-dadaa90af4c2Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75389-005-01Hand Sanitizer100 mL in 1 BOTTLEGEL1001
75389-005-02Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75389-005HAND SANITIZER GEL [HUIZHOU MAXSEE BIOLOGICAL TECHNOLOGY CO.,LTD.]1Legacy NDC, 2 package rows20200430_a4067078-9944-4e6f-e053-2995a90ab142.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
75389-00575389-005-01, 75389-005-02

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
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 934Z135WT9208IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML · Source PDF

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
a406728c-e032-f673-e053-2a95a90a438aa4067078-9944-4e6f-e053-2995a90ab1422020-04-24WarningsExact identifier
spl id: a406728c-e032-f673-e053-2a95a90a438a
spl set id: a4067078-9944-4e6f-e053-2995a90ab142

Reported adverse events (FAERS/openFDA)#

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