Antibacterial Hand Wipes by GK Global Manufacturing Inc. Antibacterial Hand Wipes

Antibacterial Hand Wipes by

Drug Labeling and Warnings

Antibacterial Hand Wipes by is a Otc medication manufactured, distributed, or labeled by GK Global Manufacturing Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth 
GK Global Manufacturing Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antibacterial Hand Wipes

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antimicrobial

Uses

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

Warnings

for external use only

When using this product

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

Stop use and ask a doctor

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

Keep out of reach of children.

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

Directions

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

Store in a cool dry place

Inactive ingredients

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

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 Labeling: 50ct

ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79527-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
CITRAL (UNII: T7EU0O9VPP)
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79527-000-20	20 in 1 PACKAGE	08/01/2020	12/01/2021
1		6.8 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 79527-000-50	50 in 1 PACKAGE	08/01/2020	12/01/2021
2		6.8 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2020	12/01/2021

Labeler - GK Global Manufacturing Inc. (038766670)

Revised: 2/2022

Document Id: d6f684b4-f836-e154-e053-2a95a90a64f9

34390-5

Set id: ab6f375d-fafa-9bab-e053-2995a90a8916

Version: 2

Effective Time: 20220201