FDA.reportPublic FDA data

BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes

Manufacturer
QUEST USA CORP. | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:30:30

Label at a glance#

ProductBioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12%

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 if

OTC - STOP USE SECTION

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

SPL UNCLASSIFIED SECTION

• Store in a cool, dry place, between 15°-30° (59°-86°F). • Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

Questions?

OTC - QUESTIONS SECTION

call 718-975-2586

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038741benzalkonium Cl 0.12 % Medicated PadPSN5
1038741benzalkonium chloride 1.2 MG/ML Medicated PadSCD5
1038741benzalkonium chloride 0.12 % Medicated WipeSY5
1038741benzalkonium chloride 0.12 % Topical ClothSY5
1038741benzalkonium chloride 0.12 % Topical SwabSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130842700165159GTIN-13: 0842700165159
EAN-13: 0842700165159
GTIN-12: 842700165159
UPC-A: 842700165159
GTIN storage (14 digits): 00842700165159		Label2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-009-00BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes250 in 1 CONTAINERCLOTH2505
78691-009-00BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes2.8 mL in 1 PATCHCLOTH2.85

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78691-00978691-009-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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 Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 WipesBENZALKONIUM CHLORIDEQUEST USA CORP.ae2fdb32-05c6-6d16-e053-2995a90a552d2025-12-31WarningsExact identifier
ndc (package): 78691-009-00
ndc (product): 78691-009
ndc11 (package): 78691000900
spl id: 47485d18-f49b-df6b-e063-6294a90a46a4
spl set id: ae2fdb32-05c6-6d16-e053-2995a90a552d

Reported adverse events (FAERS/openFDA)#

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