ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

Antibacterial Hand Wipes by

Drug Labeling and Warnings

Antibacterial Hand Wipes by is a Otc medication manufactured, distributed, or labeled by AMERICAN EXCHANGE TIME LLC, Kangna (Zhejiang) Medical Supplies Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13 %

Purpose

Antimicrobial Agent

USE

Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap
and water are not available.

Warning

For external use only. Do not use:
●In children less than 2 months of age.
●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 iritation 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. .

Directions

Apply to hands, allow to dry without wiping. .

Inactive ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78870-901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78870-901-01	80 in 1 BAG	06/23/2020
1		420 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 78870-901-02	15 in 1 BAG	06/23/2020
2		82 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/22/2020

Labeler - AMERICAN EXCHANGE TIME LLC (830332164)

Establishment
Name	Address	ID/FEI	Business Operations
Kangna (Zhejiang) Medical Supplies Co., Ltd.		554530173	manufacture(78870-901)