FDA.reportPublic FDA data

Antibacterial Hand Wipes

Manufacturer
GK Global Manufacturing Inc.
Effective date
2020-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:19:38

Label at a glance#

ProductAntibacterial Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

• For hand sanitizing to decrease bacteria on the skin • recommended for repeated use

Dosage and administration

• Take wipe and rub throughly over all surfaces of both hands • Rub hands together briskly to dry and allow to air dry. • Dispose of wipe in trash • Do not flush.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

• For hand sanitizing to decrease bacteria on the skin
• recommended for repeated use

Warnings

WARNINGS SECTION

for external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes; in case of eye contact, flush eyes with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Take wipe and rub throughly over all surfaces of both hands • Rub hands together briskly to dry and allow to air dry. • Dispose of wipe in trash • Do not flush.

Other Information

SPL UNCLASSIFIED SECTION

• Store in a cool dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citric Acid, Polysobate 20, Citrus Aurantium Dulcis Oil, Citrus Grandis Peel Oil., Citrus Aurantium Bergamia Fruit Oil, Elettaria Cardamomum Miniscula Seed, Linalool, Ethylene Brassylate, Citral, Kumquat Base, Galaxolide.

Caution

SPL UNCLASSIFIED SECTION

To avoid risk of choking and suffocation, keep wipes, plastic bags and plastic containers away from babies and children. Plastic containers away from babies and children. Plastic containers may break resulting in small pieces and sharp edges. Plastic containers and plastic bags are not intended for use by children. Do not flush.

Package Labeling: 20ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 50ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79527-000-202022-02-01C16284748780-1d6a99b39-f87c-a426-e053-dadaa90af4c2Antibacterial Hand Wipes
79527-000-502022-02-01C16284748780-1d6a99b39-f87c-a426-e053-dadaa90af4c2Antibacterial Hand Wipes
79527-000-202022-01-28C16284748780-1d6a99b39-f87c-a426-e053-dadaa90af4c2Antibacterial Hand Wipes
79527-000-502022-01-28C16284748780-1d6a99b39-f87c-a426-e053-dadaa90af4c2Antibacterial Hand Wipes

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79527-00079527-000-20, 79527-000-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYSORBATE 207T1F30V5YHIACT
LINALOOL, (+/-)-D81QY6I88EIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
CITRALT7EU0O9VPPIACT
HEXAMETHYLINDANOPYRAN14170060ATIACT
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
d6f684b4-f836-e154-e053-2a95a90a64f9ab6f375d-fafa-9bab-e053-2995a90a89162022-02-01WarningsExact identifier
spl set id: ab6f375d-fafa-9bab-e053-2995a90a8916

Reported adverse events (FAERS/openFDA)#

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