FDA.reportPublic FDA data

77753-001 ​Hand Sanitizer Alcohol Spray Cleaner

Manufacturer
SHANDISHI Biological Technology Co., Ltd.
Effective date
2020-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:13:44

Label at a glance#

ProductHand Sanitizer Alcohol Cleaner
Active ingredientALCOHOL
Label structure6 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping Children under 6 years of age use only under adult supervision. 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

Hand and surface sanitizing.

WARNINGS SECTION

■For external use only
Flammable. Keep away from fire or flame
When using this product
n Keep out of eyes. In case of contact with eyes
flush thoroughly with water
■Avoid contact with open skin
1 Do not inhale or ingest
Stop use and ask a doctor
If skin iritation or redness develops

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

Wet hands thoroughly with product and allow to dry without wiping

Children under 6 years of age use only under adult supervision.

Not recommended for infants

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Glycerin, Propylene Glycol, Tocopheryl Acetate,
Triethanolamine, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286295ethanol 75 % Topical SprayPSN1
2286295ethanol 0.75 ML/ML Topical SpraySCD1
2286295ethanol 75 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77753-001-012022-01-28C16284748780-1d6a99b39-f2b5-a426-e053-dadaa90af4c277753-001 ​Hand Sanitizer Alcohol Spray Cleaner
77753-001-022022-01-28C16284748780-1d6a99b39-f2b5-a426-e053-dadaa90af4c277753-001 ​Hand Sanitizer Alcohol Spray Cleaner
77753-001-032022-01-28C16284748780-1d6a99b39-f2b5-a426-e053-dadaa90af4c277753-001 ​Hand Sanitizer Alcohol Spray Cleaner
77753-001-042022-01-28C16284748780-1d6a99b39-f2b5-a426-e053-dadaa90af4c277753-001 ​Hand Sanitizer Alcohol Spray Cleaner
77753-001-052022-01-28C16284748780-1d6a99b39-f2b5-a426-e053-dadaa90af4c277753-001 ​Hand Sanitizer Alcohol Spray Cleaner
77753-001-062022-01-28C16284748780-1d6a99b39-f2b5-a426-e053-dadaa90af4c277753-001 ​Hand Sanitizer Alcohol Spray Cleaner
77753-001-072022-01-28C16284748780-1d6a99b39-f2b5-a426-e053-dadaa90af4c277753-001 ​Hand Sanitizer Alcohol Spray Cleaner
77753-001-082022-01-28C16284748780-1d6a99b39-f2b5-a426-e053-dadaa90af4c277753-001 ​Hand Sanitizer Alcohol Spray Cleaner
77753-001-092022-01-28C16284748780-1d6a99b39-f2b5-a426-e053-dadaa90af4c277753-001 ​Hand Sanitizer Alcohol Spray Cleaner
77753-001-102022-01-28C16284748780-1d6a99b39-f2b5-a426-e053-dadaa90af4c277753-001 ​Hand Sanitizer Alcohol Spray Cleaner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77753-001-01Hand Sanitizer Alcohol Cleaner12 in 1 BOXSPRAY121
77753-001-01Hand Sanitizer Alcohol Cleaner10 mL in 1 BOTTLESPRAY101
77753-001-02Hand Sanitizer Alcohol Cleaner12 in 1 BOXSPRAY121
77753-001-02Hand Sanitizer Alcohol Cleaner15 mL in 1 BOTTLESPRAY151
77753-001-03Hand Sanitizer Alcohol Cleaner30 mL in 1 BOTTLESPRAY301
77753-001-03Hand Sanitizer Alcohol Cleaner12 in 1 BOXSPRAY121
77753-001-04Hand Sanitizer Alcohol Cleaner53 mL in 1 BOTTLESPRAY531
77753-001-04Hand Sanitizer Alcohol Cleaner12 in 1 BOXSPRAY121
77753-001-05Hand Sanitizer Alcohol Cleaner60 mL in 1 BOTTLESPRAY601
77753-001-05Hand Sanitizer Alcohol Cleaner12 in 1 BOXSPRAY121
77753-001-06Hand Sanitizer Alcohol Cleaner120 mL in 1 BOTTLESPRAY1201
77753-001-06Hand Sanitizer Alcohol Cleaner8 in 1 BOXSPRAY81
77753-001-07Hand Sanitizer Alcohol Cleaner8 in 1 BOXSPRAY81
77753-001-07Hand Sanitizer Alcohol Cleaner236 mL in 1 BOTTLESPRAY2361
77753-001-08Hand Sanitizer Alcohol Cleaner250 mL in 1 BOTTLESPRAY2501
77753-001-08Hand Sanitizer Alcohol Cleaner8 in 1 BOXSPRAY81
77753-001-09Hand Sanitizer Alcohol Cleaner4 in 1 BOXSPRAY41
77753-001-09Hand Sanitizer Alcohol Cleaner473 mL in 1 BOTTLESPRAY4731
77753-001-10Hand Sanitizer Alcohol Cleaner500 mL in 1 BOTTLESPRAY5001
77753-001-10Hand Sanitizer Alcohol Cleaner4 in 1 BOXSPRAY41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77753-001HAND SANITIZER ALCOHOL CLEANER (ETHYL ALCOHOL) SPRAY [SHANDISHI BIOLOGICAL TECHNOLOGY CO., LTD.]1Legacy NDC, 20 package rows20200520_a5cd8a74-0fcc-1923-e053-2a95a90a42db.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77753-00177753-001-01, 77753-001-02, 77753-001-03, 77753-001-04, 77753-001-05, 77753-001-06, 77753-001-07, 77753-001-08, 77753-001-09, 77753-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
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
a5cd8b93-73c8-453b-e053-2a95a90a95fea5cd8a74-0fcc-1923-e053-2a95a90a42db2020-05-16WarningsExact identifier
spl id: a5cd8b93-73c8-453b-e053-2a95a90a95fe
spl set id: a5cd8a74-0fcc-1923-e053-2a95a90a42db

Reported adverse events (FAERS/openFDA)#

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