FDA.reportPublic FDA data

BIOPURE 50CT ANTI BACTERIAL HAND WIPES

Manufacturer
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
Effective date
2025-09-30
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:15:22

Label at a glance#

ProductBIOPURE 50CT ANTI BACTERIAL HAND WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure19 sections

Indications and uses

●Hand sanitizer to help reduce bacteria ●For use when soap and water 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 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, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

Question?

POSTMARKETING EXPERIENCE SECTION

Call 718-975-2586

Label 79794-800-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

800-1800-1

Label 79794-800-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0202

Label 79795-800-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0303

Label 79795-800-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0404

Label 79795-800-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0505

Label 79795-800-06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0606

Label 79794-800-07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0707

Label 79794-800-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0808

Label 79794-800-09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0909

Label 79794-800-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1010

Label 79794-800-11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 79794-800-11Label 79794-800-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN8
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD8
1038558benzalkonium chloride 0.13 % Topical ClothSY8
1038558benzalkonium chloride 0.13 % Topical SwabSY8
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY8
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY8
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79794-800-012024-02-01C16284748780-11030e365-632c-111a-e063-dadaa90a10e279794-800

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79794-800-01BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH18
79794-800-01BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-02BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH18
79794-800-02BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-03BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-03BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH18
79794-800-04BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH18
79794-800-04BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-05BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 CARTONCLOTH18
79794-800-05BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-06BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 CARTONCLOTH18
79794-800-06BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-07BIOPURE 50CT ANTI BACTERIAL HAND WIPES20 in 1 CANISTERCLOTH208
79794-800-07BIOPURE 50CT ANTI BACTERIAL HAND WIPES24 in 1 CARTONCLOTH248
79794-800-08BIOPURE 50CT ANTI BACTERIAL HAND WIPES75 in 1 CANISTERCLOTH758
79794-800-08BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CARTONCLOTH128
79794-800-09BIOPURE 50CT ANTI BACTERIAL HAND WIPES20 in 1 CANISTERCLOTH208
79794-800-09BIOPURE 50CT ANTI BACTERIAL HAND WIPES24 in 1 CARTONCLOTH248
79794-800-10BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CARTONCLOTH128
79794-800-10BIOPURE 50CT ANTI BACTERIAL HAND WIPES75 in 1 CANISTERCLOTH758
79794-800-11BIOPURE 50CT ANTI BACTERIAL HAND WIPES24 in 1 CARTONCLOTH248
79794-800-11BIOPURE 50CT ANTI BACTERIAL HAND WIPES20 in 1 CANISTERCLOTH208

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79794-80079794-800-01, 79794-800-02, 79794-800-03, 79794-800-04, 79794-800-05, 79794-800-06, 79794-800-07, 79794-800-08, 79794-800-09, 79794-800-10, 79794-800-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
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
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ee484505-3bb1-2989-e053-2995a90aea2b2025-09-30WarningsExact identifier
ndc (package): 79794-800-04
ndc (package): 79794-800-07
ndc (package): 79794-800-06
ndc (package): 79794-800-11
ndc (package): 79794-800-03
ndc (package): 79794-800-02
ndc (package): 79794-800-09
ndc (package): 79794-800-08
ndc (package): 79794-800-01
ndc (package): 79794-800-05
ndc (package): 79794-800-10
ndc (product): 79794-800
ndc11 (package): 79794080008
ndc11 (package): 79794080011
ndc11 (package): 79794080007
ndc11 (package): 79794080009
ndc11 (package): 79794080004
ndc11 (package): 79794080006
ndc11 (package): 79794080010
ndc11 (package): 79794080002
ndc11 (package): 79794080001
ndc11 (package): 79794080005
ndc11 (package): 79794080003
spl id: 400f215e-b012-c880-e063-6394a90ad5c5
spl set id: ee484505-3bb1-2989-e053-2995a90aea2b

Reported adverse events (FAERS/openFDA)#

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