FDA.reportPublic FDA data

Foaming Hand Sanitizer

Manufacturer
Suzhou HVHA Medical Technology Development Co.,Ltd.
Effective date
2021-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:04

Label at a glance#

ProductFoaming Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Storage and handling

Seal and keep in cool and dark place Shelf life: 24 months

Label contents#

Full prescribing information#

Main ingredients and content

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride: 600mg/L-1000mg/L

Properties

DESCRIPTION SECTION

This product is transparent liquid

Application scope

INDICATIONS & USAGE SECTION

This product is suitable for daily hand cleaning. Use for 2 minutes have bacteriostasis on Staphylococcus aureus, E. Coli and Candida albicans.

Usage

DOSAGE & ADMINISTRATION SECTION

Press appropriate amount of foam on the palm, rub hands evenly, rinse-free.

Notices

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children shall use this product under the surveillance of adult.

This product shall be kept out of the reach of children or abnormal people.

WARNINGS SECTION

Avoid high temperature.

Do not use this product if its properties change.

Function mechanism

MECHANISM OF ACTION SECTION

Benzalkonium chloride, as a cationic surfactant, is a broad-spectrum bactericide, which can change the permeability of bacterial plasma membrane, make the cytoplasmic substance extravasate, hinder its metabolism and play a killing role.

Storage

STORAGE AND HANDLING SECTION

Seal and keep in cool and dark place

Shelf life: 24 months

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin and Polysorbate 80

Purpose

OTC - PURPOSE SECTION

Hand sanitizing

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Foaming hand sanitizer 50ml 77263-002-01 labelFoaming hand sanitizer 50ml 77263-002-01 label

Foaming hand sanitizer 100ml 77263-002-02 labelFoaming hand sanitizer 100ml 77263-002-02 label

Foaming hand sanitizer 150ml 77263-002-03 labelFoaming hand sanitizer 150ml 77263-002-03 label

Foaming hand sanitizer 200ml 77263-002-04 labelFoaming hand sanitizer 200ml 77263-002-04 label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77263-002-012023-01-30C16284748780-1f386c64a-1eda-0266-e053-dadaa90a7c1aFoaming Hand Sanitizer
77263-002-022023-01-30C16284748780-1f386c64a-1eda-0266-e053-dadaa90a7c1aFoaming Hand Sanitizer
77263-002-032023-01-30C16284748780-1f386c64a-1eda-0266-e053-dadaa90a7c1aFoaming Hand Sanitizer
77263-002-042023-01-30C16284748780-1f386c64a-1eda-0266-e053-dadaa90a7c1aFoaming Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77263-002-01Foaming Hand Sanitizer50 mL in 1 BOTTLELIQUID502
77263-002-02Foaming Hand Sanitizer100 mL in 1 BOTTLELIQUID1002
77263-002-03Foaming Hand Sanitizer150 mL in 1 BOTTLELIQUID1502
77263-002-04Foaming Hand Sanitizer200 mL in 1 BOTTLELIQUID2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77263-002FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [SUZHOU HVHA MEDICAL TECHNOLOGY DEVELOPMENT CO.,LTD.]2Legacy NDC, 4 package rows20211230_e23cee3c-7bcc-47ac-9602-9a2ddca78c28.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
77263-00277263-002-01, 77263-002-02, 77263-002-03, 77263-002-04

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
POLYSORBATE 806OZP39ZG8HIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
d447dbbd-bb88-687a-e053-2995a90af024e23cee3c-7bcc-47ac-9602-9a2ddca78c282021-12-28WarningsExact identifier
spl id: d447dbbd-bb88-687a-e053-2995a90af024
spl set id: e23cee3c-7bcc-47ac-9602-9a2ddca78c28

Reported adverse events (FAERS/openFDA)#

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