BIOPURE 1600CT ANTIBACTERIAL HAND WIPES- benzalkonium chloride patch 
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.

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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Active ingredient

0.12% Benzalkonium Chloride

Purpose

Antibacterial

Uses

●Hand sanitizer to help reduce bacteria.

●For use when soap and water are not available

Warnings

For external use only.

Do not use

●in children less than 2 months old.

●on open skin wounds.

When using this product

do not get in eyes. If contact is made rinse thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and lasts.

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 air dry without wiping.

●Children under 6 years of age should be supervised when using this product.

Other information

●Store in a cool, dry place.

●Avoid freezing and excessive heat .

Inactive ingredients

Glycerin, Phenoxyethanol, Propylene Glycol, Water

Question?

Call 718-975-2586

Package label

CT 1600

BIOPURE 1600CT ANTIBACTERIAL HAND WIPES 
benzalkonium chloride patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79794-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79794-112-014 in 1 CARTON08/30/2023
11600 in 1 POUCH
10.77 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/30/2023
Labeler - Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. (723796509)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.723796509manufacture(79794-112)

Revised: 8/2023
Document Id: 042149c9-a207-8462-e063-6394a90a7252
Set id: 042149c9-a206-8462-e063-6394a90a7252
Version: 1
Effective Time: 20230830
 
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.