BioPure by QUEST USA CORP BioPure Wipes

BioPure by

Drug Labeling and Warnings

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

Drug Details [pdf]

BIOPURE- 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 Wipes

Drug Facts

Active ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

• 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.

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 or 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.
• Discard wipe in trash receptacle after use.
• Do not flush.

Other Information

• Store in a cool, dry place, betwen 15°-30°C (59°F-86°F).
• Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

Purified water USP

Questions?

call 718-975-2586

Package Labeling:78691-001-50

Package Labeling:78691-001-10

BIOPURE 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78691-001
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: 78691-001-40	40 in 1 POUCH	06/18/2020	09/02/2020
1		4 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 78691-001-50	50 in 1 POUCH	06/18/2020	06/01/2021
2		4 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 78691-001-10	100 in 1 CANISTER	06/18/2020	06/01/2021
3		4 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	06/18/2020	06/01/2021

Labeler - QUEST USA CORP (079869689)

Revised: 7/2021

Document Id: c78fd8ed-6ce4-c84f-e053-2a95a90ac398

34390-5

Set id: a9008c4e-9b99-241b-e053-2a95a90a1c27

Version: 3

Effective Time: 20210720