Biopure Antibacterial Hand Wipes

Antibacterial Hand Wipes by

Drug Labeling and Warnings

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]

ANTIBACTERIAL HAND WIPES- biopure antibacterial hand wipes 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

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Purpose

Antibacterial

Use

For Hand Sanitizer to decrease bacterial on the skin

Warnings

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

Do not use

• in children less than 2 months of age
• 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 appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

peel the sticker when you use it.

Easily get one wipe at a time.

After application, please re-seal the opening sticker firmly to prevent wipes from drying out

Other information

• Store between 0-40C (32-104F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

pure water

Package Label - Principal Display Panel

100 wipes in 1 bag. NDC: 78691-001-01;

ANTIBACTERIAL HAND WIPES 
biopure antibacterial hand wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78691-018
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	0.001 U  in 1 U
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78691-018-02	100 U in 1 CANISTER; Type 0: Not a Combination Product	07/01/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020	12/31/2022

Labeler - QUEST USA CORP (079869689)

Establishment
Name	Address	ID/FEI	Business Operations
QUEST USA CORP		079869689	label(78691-018) , manufacture(78691-018)

Revised: 12/2022

Document Id: f0e46dec-2e4c-9447-e053-2a95a90a2ea3

34390-5

Set id: a7ca7d94-d72b-5623-e053-2a95a90a4df8

Version: 3

Effective Time: 20221228