ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth 
AMERICAN EXCHANGE TIME LLC

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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78870-901 Antibacterial Hand Wipes 0.13% Benzalkonium Chloride

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

1

ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78870-901
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78870-901-0180 in 1 BAG06/23/2020
1420 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:78870-901-0215 in 1 BAG06/23/2020
282 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/22/2020
Labeler - AMERICAN EXCHANGE TIME LLC (830332164)
Establishment
NameAddressID/FEIBusiness Operations
Kangna (Zhejiang) Medical Supplies Co., Ltd.554530173manufacture(78870-901)

Revised: 6/2020
Document Id: a8b5a9b6-fb28-a631-e053-2a95a90a7ad3
Set id: a8b5bc16-8203-dfc7-e053-2a95a90a524e
Version: 1
Effective Time: 20200622
 
AMERICAN EXCHANGE TIME LLC