BioPure Antibacterial Hand Wipes Citrus Scent

BioPure Antibacterial Hand Wipes Citrus Scent by

Drug Labeling and Warnings

BioPure Antibacterial Hand Wipes Citrus Scent by is a Otc medication manufactured, distributed, or labeled by QUEST USA CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOPURE ANTIBACTERIAL HAND WIPES CITRUS SCENT- 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 Citrus Scent

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

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

Aloe Barbadensis Extract, Alpha-Tocopherol, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

Questions?

call 718-975-2586

Package Labeling:

BIOPURE ANTIBACTERIAL HAND WIPES CITRUS SCENT 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78691-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78691-014-00	40 in 1 POUCH	09/30/2020	12/31/2022
1		4.25 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 not final	part333E	09/30/2020	12/31/2022

Labeler - QUEST USA CORP. (079869689)

Revised: 12/2022

Document Id: ef55b1d6-ef0c-3685-e053-2995a90a6bb4

34390-5

Set id: b0b4f308-6524-1684-e053-2995a90a8d5f

Version: 2

Effective Time: 20221208