FDA.reportPublic FDA data

BioPure Antibacterial Hand Wipes Citrus Scented

Manufacturer
Zhejiang iColor Biotech Co., Ltd
Effective date
2024-01-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:12:43

Label at a glance#

ProductBioPure Antibacterial Hand Wipes Citrus Scented
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 0.13%

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 of age.
  • 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 Contol 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°C (59°F-86°F).
  • Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Polyaminopropyl Biguanide, Propylene Glycol, Purified Water

Questions?

OTC - QUESTIONS SECTION

call 718-975-2586

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74934-074BIOPURE ANTIBACTERIAL HAND WIPES CITRUS SCENTED (BENZALKONIUM CHLORIDE) CLOTH [ZHEJIANG ICOLOR BIOTECH CO., LTD]2Legacy NDC20240125_b5e5ce93-b691-4851-e053-2a95a90adb86.zip

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
74934-07474934-074-20

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
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETIACT
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
0fb4403b-2e96-4ca0-e063-6294a90a05acb5e5ce93-b691-4851-e053-2a95a90adb862024-01-24WarningsExact identifier
spl id: 0fb4403b-2e96-4ca0-e063-6294a90a05ac
spl set id: b5e5ce93-b691-4851-e053-2a95a90adb86

Reported adverse events (FAERS/openFDA)#

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