BIOPURE ANTIBACTERIAL HAND WIPES BENZALKONIUM CHLORIDE 0.12% - 250 WIPES- benzalkonium chloride cloth 
QUEST USA CORP.

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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BioPure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes

Drug Facts

Active ingredient

Benzalkonium Chloride 0.12%

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

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

irritation 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 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, Methylchloroisothiazolinone, Phenoxyethanol, Propylene Glycol, Purified Water

Questions?

call 718-975-2586

Package Labeling:

Box

BIOPURE ANTIBACTERIAL HAND WIPES BENZALKONIUM CHLORIDE 0.12% - 250 WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78691-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78691-009-00250 in 1 CONTAINER09/20/2020
12.8 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/20/2020
Labeler - QUEST USA CORP. (079869689)

Revised: 8/2020
Document Id: ae2fb7a3-a246-6d14-e053-2995a90a0df4
Set id: ae2fdb32-05c6-6d16-e053-2995a90a552d
Version: 1
Effective Time: 20200831
 
QUEST USA CORP.