BIOPURE 50CT ANTI BACTERIAL HAND WIPES — v8

BIOPURE 50CT ANTI BACTERIAL HAND WIPES

3 Views

Version

v8

Effective date

September 30, 2025

Original packager

Yes

Sections captured

14

Identifiers

Document ID
400f215e-b012-c880-e063-6394a90ad5c5
Set ID
ee484505-3bb1-2989-e053-2995a90aea2b
Application numbers
M003
Product NDCs
79794-800
Package NDCs
79794-800-01, 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
Original packager NDCs
—

Names & Manufacturers

Brand names
BIOPURE 50CT ANTI BACTERIAL HAND WIPES
Generic names
BENZALKONIUM CHLORIDE
Manufacturer names
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
BENZALKONIUM CHLORIDE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
F5UM2KM3W7
UPC
0810146465393, 0810146465409

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Benzalkonium Chloride 0.13%
Do Not Use (1)

Sequence 1

Do not use ●in children less than 2 months old. ●on open skin wounds
Dosage And Administration (1)

Sequence 1

Directions ●Apply to hands, allow to air dry without wiping. ●Children under 6 years of age should be supervised when using this product
Inactive Ingredient (1)

Sequence 1

Inactive ingredients Aloe Barbadensis Leaf Extract, Alpha-Tocopherol, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water
Indications And Usage (1)

Sequence 1

Uses ●Hand sanitizer to help reduce bacteria ●For use when soap and water not available.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed. get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (11)

Sequence 1

Label 79794-800-01 800-1

Sequence 2

Label 79794-800-02 02

Sequence 3

Label 79795-800-03 03

Sequence 4

Label 79795-800-04 04

Sequence 5

Label 79795-800-05 05

Sequence 6

Label 79795-800-06 06

Sequence 7

Label 79794-800-07 07

Sequence 8

Label 79794-800-08 08

Sequence 9

Label 79794-800-09 09

Sequence 10

Label 79794-800-10 10

Sequence 11

Label 79794-800-11 Label 79794-800-11
Purpose (1)

Sequence 1

Purpose Antibacterial
Spl Product Data Elements (1)

Sequence 1

BIOPURE 50CT ANTI BACTERIAL HAND WIPES Benzalkonium Chloride PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL, DL- ALOE VERA LEAF GLYCERIN PHENOXYETHANOL WATER BENZALKONIUM CHLORIDE BENZALKONIUM
Spl Unclassified Section (1)

Sequence 1

Question? Call 718-975-2586
Stop Use (1)

Sequence 1

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition
Storage And Handling (1)

Sequence 1

Other Information ●Store in a cool, dry place. ●Avoid freezing and excessive heat.
Warnings (1)

Sequence 1

Warnings For external use only. Do not use ●in children less than 2 months old. ●on open skin wounds When using this product 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 irritation or rash occurs. These may be signs of a serious condition Keep out of reach of children. If swallowed. get medical help or contact a Poison Control Center right away.
When Using (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['M003'],
 'brand_name': ['BIOPURE 50CT ANTI BACTERIAL HAND WIPES'],
 'generic_name': ['BENZALKONIUM CHLORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.'],
 'package_ndc': ['79794-800-01',
                 '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'],
 'product_ndc': ['79794-800'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['400f215e-b012-c880-e063-6394a90ad5c5'],
 'spl_set_id': ['ee484505-3bb1-2989-e053-2995a90aea2b'],
 'substance_name': ['BENZALKONIUM CHLORIDE'],
 'unii': ['F5UM2KM3W7'],
 'upc': ['0810146465409', '0810146465393']}