FDA.reportPublic FDA data

Biopure Antibacterial Hand Wipe

Manufacturer
Quest USA Corp
Effective date
2025-08-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:10:02

Label at a glance#

ProductBiopure Antibacterial Hand Wipe
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.

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 ues 

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

SPL UNCLASSIFIED 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

Questions?

OTC - QUESTIONS SECTION

call 718-975-2586

78691-017-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

78691-017-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN5
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD5
1038558benzalkonium chloride 0.13 % Topical ClothSY5
1038558benzalkonium chloride 0.13 % Topical SwabSY5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY5
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-017-00Biopure Antibacterial Hand Wipe50 in 1 CANISTERCLOTH505
78691-017-00Biopure Antibacterial Hand Wipe2.9 mL in 1 PATCHCLOTH2.95
78691-017-01Biopure Antibacterial Hand Wipe50 in 1 CANISTERCLOTH505
78691-017-01Biopure Antibacterial Hand Wipe3.4 mL in 1 PATCHCLOTH3.45

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
78691-01778691-017-00, 78691-017-01

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
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
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 WipeBENZALKONIUM CHLORIDEQuest USA Corp17b907cf-ae7d-49bd-9624-cd708dbb011e2025-08-12WarningsExact identifier
ndc (package): 78691-017-00
ndc (package): 78691-017-01
ndc (product): 78691-017
ndc11 (package): 78691001701
ndc11 (package): 78691001700
spl id: 3c320378-aacc-a884-e063-6394a90abe6c
spl set id: 17b907cf-ae7d-49bd-9624-cd708dbb011e

Reported adverse events (FAERS/openFDA)#

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