FDA.reportPublic FDA data

BIOPURE 40CT ANTI BACTERIAL HAND WIPES

Manufacturer
QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:05:21

Label at a glance#

ProductBIOPURE 40CT ANTI BACTERIAL HAND WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

●Hand sanitizer to help reduce bacteria ●For use when soap and water are not available.

Dosage and administration

●Apply to hands, allow to air dry without wiping. ●Children under 6 years of age should be supervised when using this product

Storage and handling

●Store in a cool, dry place. ●Avoid freezing and excessive heat

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

●Hand sanitizer to help reduce bacteria

●For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

●in children less than 2 months old.

●on open skin wounds

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs.

These may be signs of a serious condition

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed. get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

●Apply to hands, allow to air dry without wiping.
●Children under 6 years of age should be supervised when using this product

Other information

STORAGE AND HANDLING SECTION

●Store in a cool, dry place.

●Avoid freezing and excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Alpha-Tocopherol, Ethylhexylglycerin, Fragrance, Glycerin, Iodopropynyl Butylcarbamate, Phenoxyethanol, Propylene Glycol, Water

Question?

POSTMARKETING EXPERIENCE SECTION

Call 718-975-2586

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

09-0109-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83535-009-012025-01-30C16284748780-12cef2736-5f12-d83d-e063-dadaa90ab31f83535-009-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83535-009-01BIOPURE 40CT ANTI BACTERIAL HAND WIPES12 in 1 CARTONCLOTH121
83535-009-01BIOPURE 40CT ANTI BACTERIAL HAND WIPES40 in 1 POUCHCLOTH401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83535-009BIOPURE 40CT ANTI BACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD]12 package rows20231222_0cffcc42-a970-d540-e063-6394a90ae977.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83535-00983535-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALPHA-TOCOPHEROLH4N855PNZ1IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
0cffd254-947d-e497-e063-6394a90a53c90cffcc42-a970-d540-e063-6394a90ae9772023-12-21WarningsExact identifier
spl id: 0cffd254-947d-e497-e063-6394a90a53c9
spl set id: 0cffcc42-a970-d540-e063-6394a90ae977

Reported adverse events (FAERS/openFDA)#

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