FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Wenzhou Shengkai Technology Industry Co., Ltd.
Effective date
2021-02-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:44

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure6 sections

Dosage and administration

Take out the product and spread it on your skin until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethy Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Use:Help reduce bacteria that potentially can cause disease.

WARNINGS SECTION

For externaluse on/y. Flammable. Keep away from heat o1 flame.
Do not use
In children less than 2 months of age On open skin wounds.
Allergic to alcohol
When using this product
Keep out ofeyes, ears, and mouth./n case of contact with eyes,
rinse eyes thoroughly with water.
Stop use: stop use and ask a doctor if irritation or rash occurs

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

Take out the product and spread it on your skin until dry.
Supervise children under 6 years of age when using this product to
avoid swallowing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78019-800-012023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer
78019-800-022023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer
78019-800-032023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer
78019-800-042023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer
78019-800-052023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer
78019-800-062023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer
78019-800-072023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer
78019-800-082023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer
78019-800-092023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer
78019-800-102023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer
78019-800-112023-01-30C16284748780-1f386c64a-4894-0266-e053-dadaa90a7c1a78019-800 ​75% Alcohol Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78019-800-01Hand Sanitizer2 mL in 1 BAGGEL22
78019-800-02Hand Sanitizer3 mL in 1 BAGGEL32
78019-800-03Hand Sanitizer5 mL in 1 BAGGEL52
78019-800-04Hand Sanitizer10 mL in 1 BAGGEL102
78019-800-05Hand Sanitizer30 mL in 1 BOTTLEGEL302
78019-800-06Hand Sanitizer60 mL in 1 BOTTLEGEL602
78019-800-07Hand Sanitizer50 mL in 1 BOTTLEGEL502
78019-800-08Hand Sanitizer100 mL in 1 BOTTLEGEL1002
78019-800-09Hand Sanitizer120 mL in 1 BOTTLEGEL1202
78019-800-10Hand Sanitizer250 mL in 1 BOTTLEGEL2502
78019-800-11Hand Sanitizer500 mL in 1 BOTTLEGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78019-800HAND SANITIZER (ETHYL ALCOHOL) GEL [WENZHOU SHENGKAI TECHNOLOGY INDUSTRY CO., LTD.]2Legacy NDC, 11 package rows20210204_a92e93c1-5183-5fae-e053-2995a90ada20.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78019-80078019-800-01, 78019-800-02, 78019-800-03, 78019-800-04, 78019-800-05, 78019-800-06, 78019-800-07, 78019-800-08, 78019-800-09, 78019-800-10, 78019-800-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
ba65f0f4-baa4-62a2-e053-2995a90af449a92e93c1-5183-5fae-e053-2995a90ada202021-02-02WarningsExact identifier
spl id: ba65f0f4-baa4-62a2-e053-2995a90af449
spl set id: a92e93c1-5183-5fae-e053-2995a90ada20

Reported adverse events (FAERS/openFDA)#

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