FDA.reportPublic FDA data

77753-003 ​Hand Sanitizer Alcohol Spray

Manufacturer
SHANDISHI Biological Technology Co., Ltd.
Effective date
2020-05-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:15:25

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure6 sections

Dosage and administration

●Place enough product in your palm to thoroughly cover your hands.●Children under 6 years of age should be supervised when using this product.●Rub hands together briskly until dry.●Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

WARNINGS SECTION

Flammable, Keep away fromn fire or flame.
For external use only
When using this product avoid contact with eyes. If
contact occurs rinse eyes thoroughly with water.
Stop use and ask a doctor if skin iritation or rash develops
and continues for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children
If swallowed , get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

●Place enough product in your palm to thoroughly cover
your hands.●Children under 6 years of age should be
supervised when using this product.●Rub hands together
briskly until dry.●Not recommended for infants.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera leaf juice, Glycerin, Fragrance(parfum) ,Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

111111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286295ethanol 75 % Topical SprayPSN2
2286295ethanol 0.75 ML/ML Topical SpraySCD2
2286295ethanol 75 % Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77753-003-012022-01-28C16284748780-1d6a99b39-8d36-a426-e053-dadaa90af4c277753-003 ​Hand Sanitizer Alcohol Spray
77753-003-022022-01-28C16284748780-1d6a99b39-8d36-a426-e053-dadaa90af4c277753-003 ​Hand Sanitizer Alcohol Spray
77753-003-032022-01-28C16284748780-1d6a99b39-8d36-a426-e053-dadaa90af4c277753-003 ​Hand Sanitizer Alcohol Spray
77753-003-042022-01-28C16284748780-1d6a99b39-8d36-a426-e053-dadaa90af4c277753-003 ​Hand Sanitizer Alcohol Spray
77753-003-052022-01-28C16284748780-1d6a99b39-8d36-a426-e053-dadaa90af4c277753-003 ​Hand Sanitizer Alcohol Spray
77753-003-062022-01-28C16284748780-1d6a99b39-8d36-a426-e053-dadaa90af4c277753-003 ​Hand Sanitizer Alcohol Spray
77753-003-072022-01-28C16284748780-1d6a99b39-8d36-a426-e053-dadaa90af4c277753-003 ​Hand Sanitizer Alcohol Spray
77753-003-082022-01-28C16284748780-1d6a99b39-8d36-a426-e053-dadaa90af4c277753-003 ​Hand Sanitizer Alcohol Spray
77753-003-092022-01-28C16284748780-1d6a99b39-8d36-a426-e053-dadaa90af4c277753-003 ​Hand Sanitizer Alcohol Spray
77753-003-102022-01-28C16284748780-1d6a99b39-8d36-a426-e053-dadaa90af4c277753-003 ​Hand Sanitizer Alcohol Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77753-003-01Hand Sanitizer12 in 1 BOXSPRAY122
77753-003-01Hand Sanitizer10 mL in 1 BOTTLESPRAY102
77753-003-02Hand Sanitizer12 in 1 BOXSPRAY122
77753-003-02Hand Sanitizer15 mL in 1 BOTTLESPRAY152
77753-003-03Hand Sanitizer20 mL in 1 BOTTLESPRAY202
77753-003-03Hand Sanitizer12 in 1 BOXSPRAY122
77753-003-04Hand Sanitizer30 mL in 1 BOTTLESPRAY302
77753-003-04Hand Sanitizer2 in 1 BOXSPRAY22
77753-003-05Hand Sanitizer12 in 1 BOXSPRAY122
77753-003-05Hand Sanitizer50 mL in 1 BOTTLESPRAY502
77753-003-06Hand Sanitizer8 in 1 BOXSPRAY82
77753-003-06Hand Sanitizer60 mL in 1 BOTTLESPRAY602
77753-003-07Hand Sanitizer120 mL in 1 BOTTLESPRAY1202
77753-003-07Hand Sanitizer8 in 1 BOXSPRAY82
77753-003-08Hand Sanitizer8 in 1 BOXSPRAY82
77753-003-08Hand Sanitizer300 mL in 1 BOTTLESPRAY3002
77753-003-09Hand Sanitizer500 mL in 1 BOTTLESPRAY5002
77753-003-09Hand Sanitizer4 in 1 BOXSPRAY42
77753-003-10Hand Sanitizer4 in 1 BOXSPRAY42
77753-003-10Hand Sanitizer1000 mL in 1 BOTTLESPRAY10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77753-003HAND SANITIZER (ETHYL ALCOHOL) SPRAY [SHANDISHI BIOLOGICAL TECHNOLOGY CO., LTD.]2Legacy NDC, 20 package rows20200531_a6bf1cb1-1073-94f2-e053-2a95a90ae4af.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77753-00377753-003-01, 77753-003-02, 77753-003-03, 77753-003-04, 77753-003-05, 77753-003-06, 77753-003-07, 77753-003-08, 77753-003-09, 77753-003-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB

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
a6eb36ef-0e36-1454-e053-2995a90a9441a6bf1cb1-1073-94f2-e053-2a95a90ae4af2020-05-31WarningsExact identifier
spl id: a6eb36ef-0e36-1454-e053-2995a90a9441
spl set id: a6bf1cb1-1073-94f2-e053-2a95a90ae4af

Reported adverse events (FAERS/openFDA)#

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