FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD
Effective date
2021-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:52

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Ethanol 64% w/w

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Uses：

  • for hand-washing to decrease bacteria on the skin when water is not available.

WARNINGS SECTION

Warnings:

FLAMMABLE. Keep away from fire or flame

For external use only.

OTC - WHEN USING SECTION

When using this product

  • do not use in or near eyes
  • do not use on deep or puncture wounds; consult your doctor

OTC - STOP USE SECTION

  • discotinue use if irritation and redness develop.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • apply gel liberally to unsoiled hands and rub in thoroughly.
  • allow to dry without wiping or rinsing.

OTHER SAFETY INFORMATION

Other information:

  • store at room temperature.

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #5, Fragrance, Glycereth-2 Cocoate, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Triethanolamine, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of hand sanitizer 532mlimage of hand sanitizer 532mlimage of hand sanitizer 800mlimage of hand sanitizer 800mlimage of hand sanitizer 118mlimage of hand sanitizer 118ml

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130044600323749GTIN-13: 0044600323749
EAN-13: 0044600323749
GTIN-12: 044600323749
UPC-A: 044600323749
GTIN storage (14 digits): 00044600323749		118ml.jpg
BarcodeEAN-130044600323756GTIN-13: 0044600323756
EAN-13: 0044600323756
GTIN-12: 044600323756
UPC-A: 044600323756
GTIN storage (14 digits): 00044600323756		532ml.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47993-327-012025-01-30C16284748780-12cef2736-69e6-d83d-e063-dadaa90ab31f47993-327
47993-327-022025-01-30C16284748780-12cef2736-69e6-d83d-e063-dadaa90ab31f47993-327
47993-327-032025-01-30C16284748780-12cef2736-69e6-d83d-e063-dadaa90ab31f47993-327

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47993-327-01HAND SANITIZER118 mL in 1 BOTTLEGEL1181
47993-327-02HAND SANITIZER532 mL in 1 BOTTLE, PUMPGEL5321
47993-327-03HAND SANITIZER800 mL in 1 BAGGEL8001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47993-327HAND SANITIZER (ETHYL ALCOHOL) GEL [NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD]1Legacy NDC, 3 package rows20210617_c6fae508-d307-438e-915e-7ecdc5844e3d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47993-32747993-327-01, 47993-327-02, 47993-327-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
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
c4f14787-9e1d-ffbb-e053-2a95a90a89b8c6fae508-d307-438e-915e-7ecdc5844e3d2021-06-17WarningsExact identifier
spl id: c4f14787-9e1d-ffbb-e053-2a95a90a89b8
spl set id: c6fae508-d307-438e-915e-7ecdc5844e3d

Reported adverse events (FAERS/openFDA)#

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