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.

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BioPure Antibacterial Hand Wipes, 75% Ethyl Alcohol

Drug Facts

Active ingredient

Ethyl Alcohol 75%

Purpose

Antibacterial

Uses

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

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 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, between 15°-30°C (59°F-86°F).
• Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredient

Purified water USP

Questions?

call 718-975-2586

Package Labeling:50 wipes

Package Labeling:100 wipes

BIOPURE ANTIBACTERIAL HAND WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78691-019
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: 78691-019-50	50 in 1 BAG	10/29/2020	12/31/2022
1		5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 78691-019-00	100 in 1 CANISTER	10/29/2020	12/31/2022
2		5 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)	10/29/2020	12/31/2022

Labeler - QUEST USA CORP. (079869689)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang iColor Biotech CO.,LTD		554528308	manufacture(78691-019)

Revised: 2/2024

Document Id: 1134ab8a-4e45-905d-e063-6394a90ac34b

34390-5

Set id: b2a911bd-61cd-495b-e053-2995a90a2211

Version: 4

Effective Time: 20240212