FDA.reportPublic FDA data

SUDESAN Hand Sanitizer Original

Manufacturer
Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch
Effective date
2020-05-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:14:24

Label at a glance#

ProductSUDESAN Hand Sanitizer Original
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Pump as needed into your palms and thoroughly spread on both hands Rub into skin until dry.

Storage and handling

Store at 20C (68 to 77F) May discolor fabrics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NA

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help decrease bacterial on the skin

When water, soap and towel are not available

Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame. 

Do not apply around eyes. 

Do not use in ears and mouth.

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes. In case of contact, flush eyes with water

OTC - STOP USE SECTION

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Children must be supervised in use of this products.

Directions

DOSAGE & ADMINISTRATION SECTION

Pump as needed into your palms and thoroughly spread on both hands

Rub into skin until dry.

Other information

STORAGE AND HANDLING SECTION

Store at 20C (68 to 77F)

May discolor fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, carbomer, triethanolamine, glycerol, aloe barbadensis leaf juice

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN2
247835ethanol 0.62 ML/ML Topical SolutionSCD2
247835ethanol 62 % Topical SolutionSY2
247835ethyl alcohol 62 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75112-002-012022-01-28C16284748780-1d6a99b39-a7a2-a426-e053-dadaa90af4c2fd8f14d8-8292-491b-9c66-1bd9767e5fda
75112-002-022022-01-28C16284748780-1d6a99b39-a7a2-a426-e053-dadaa90af4c2fd8f14d8-8292-491b-9c66-1bd9767e5fda
75112-002-032022-01-28C16284748780-1d6a99b39-a7a2-a426-e053-dadaa90af4c2fd8f14d8-8292-491b-9c66-1bd9767e5fda
75112-002-042022-01-28C16284748780-1d6a99b39-a7a2-a426-e053-dadaa90af4c2fd8f14d8-8292-491b-9c66-1bd9767e5fda
75112-002-052022-01-28C16284748780-1d6a99b39-a7a2-a426-e053-dadaa90af4c2fd8f14d8-8292-491b-9c66-1bd9767e5fda
75112-002-062022-01-28C16284748780-1d6a99b39-a7a2-a426-e053-dadaa90af4c2fd8f14d8-8292-491b-9c66-1bd9767e5fda
75112-002-072022-01-28C16284748780-1d6a99b39-a7a2-a426-e053-dadaa90af4c2fd8f14d8-8292-491b-9c66-1bd9767e5fda
75112-002-082022-01-28C16284748780-1d6a99b39-a7a2-a426-e053-dadaa90af4c2fd8f14d8-8292-491b-9c66-1bd9767e5fda

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75112-002-01SUDESAN Hand Sanitizer Original100 mL in 1 BOTTLESOLUTION1002
75112-002-02SUDESAN Hand Sanitizer Original237 mL in 1 BOTTLESOLUTION2372
75112-002-03SUDESAN Hand Sanitizer Original300 mL in 1 BOTTLESOLUTION3002
75112-002-04SUDESAN Hand Sanitizer Original500 mL in 1 BOTTLESOLUTION5002
75112-002-05SUDESAN Hand Sanitizer Original1000 mL in 1 BOTTLESOLUTION10002
75112-002-06SUDESAN Hand Sanitizer Original2000 mL in 1 BOTTLESOLUTION20002
75112-002-07SUDESAN Hand Sanitizer Original3780 mL in 1 BOTTLESOLUTION37802
75112-002-08SUDESAN Hand Sanitizer Original30 mL in 1 BOTTLESOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75112-002SUDESAN HAND SANITIZER ORIGINAL (ALCOHOL) SOLUTION [ZHEJIANG SHENYING TECHNOLOGY CO., LTD. JIAOJIANG BRANCH]2Legacy NDC, 8 package rows20200523_fd8f14d8-8292-491b-9c66-1bd9767e5fda.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
75112-00275112-002-01, 75112-002-02, 75112-002-03, 75112-002-04, 75112-002-05, 75112-002-06, 75112-002-07, 75112-002-08

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
GLYCEROL FORMAL3L7GR2604EIACT
CARBOMER 934Z135WT9208IACT
TROLAMINE9O3K93S3TKIACT
TOCOPHEROLR0ZB2556P8IACT
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
a6414584-2a03-1d42-e053-2995a90a7b5bfd8f14d8-8292-491b-9c66-1bd9767e5fda2020-05-22WarningsExact identifier
spl id: a6414584-2a03-1d42-e053-2995a90a7b5b
spl set id: fd8f14d8-8292-491b-9c66-1bd9767e5fda

Reported adverse events (FAERS/openFDA)#

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