BIOPURE ANTIBACTERIAL HAND WIPE- benzalkonium chloride cloth

Biopure antibacterial hand wipe by

Drug Labeling and Warnings

Biopure antibacterial hand wipe by is a Otc medication manufactured, distributed, or labeled by QUEST USA CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium Chloride 0.12%

Purpose

Antimicrobial

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, Purified Water

Question?

call 718-975-2586

Package Labeling:1600ct

Package Labeling:800ct

Package Labeling:50ct

Package Labeling:100ct

INGREDIENTS AND APPEARANCE

BIOPURE ANTIBACTERIAL HAND WIPE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78691-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78691-004-00	1600 in 1 BAG	09/15/2020
1		3.44 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 78691-004-01	800 in 1 BAG	09/15/2020	10/09/2022
2		3.25 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 78691-004-02	50 in 1 POUCH	09/15/2020	09/14/2022
3		5.7 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4	NDC: 78691-004-03	100 in 1 CANISTER	09/15/2020	09/22/2022
4		5.37 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 Drug	505G(a)(3)	09/15/2020

Labeler - QUEST USA CORP. (079869689)