BioPure Antibacterial Hand Wipes, 75% Ethyl Alcohol

BioPure Antibacterial Hand Wipes by

Drug Labeling and Warnings

BioPure Antibacterial Hand Wipes 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- alcohol 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, 75% Ethyl Alcohol

Drug Facts

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

• Hand sanitizer to help reduce bacteria that potentially cause disease.
• For use when soap and water are not available.

Warnings

For external use only.  Flammable.  Keep away from heat or flame.

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 dry without wiping.
• Discard wipes in trash receptacle after use.
• Do not flush.

​Other information

• Store in a cool, dry place, between 15 o​-30 o​C (59 o-86 o​F)
• Avoid freezing and excessive heat above 40 oC (104 o​F)

Inactive ingredient

Purified water USP

Question?

call 718-975-2586

Package Labeling:

BIOPURE ANTIBACTERIAL HAND WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78691-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78691-002-16	1600 in 1 BAG	09/05/2020	12/31/2022
1		3.125 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	09/05/2020	12/31/2022

Labeler - Quest USA Corp (079869689)

Revised: 12/2022

Document Id: ef54fd3d-1c11-4f3c-e053-2a95a90a5f06

34390-5

Set id: ac8ad411-8b90-7952-e053-2a95a90ae772

Version: 2

Effective Time: 20221208