Biopure personal protective KIT

Biopure personal protective by

Drug Labeling and Warnings

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

Drug Details [pdf]

BIOPURE PERSONAL PROTECTIVE- alcohol 
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.

----------

Biopure personal protective KIT

Drug Facts

Active ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

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 ears, eyes 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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 59°-86°F (15°-30°C)
• Do not store above 104°F (40°C

Inactive ingredients

Carbopol 940, Glycerine, Propylene Glycol, Triethanolamine, Water (Aqua)

Questions?

Call 718-975-2586

Drug Facts

Active ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

• Hand antiseptic 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 ears, eyes 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.
• Supervise children under 6 years of age when using this product.

Other information

• Store between 59°-86°F (15°-30°C)
• Do not store above 104°F (40°C

Inactive ingredients

Purified Water USP

Questions?

Call 718-975-2586

Package Labeling:Kit

Package Labeling:78691-006-00

Package Labeling:78691-007-00

BIOPURE PERSONAL PROTECTIVE 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78691-005

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78691-005-00	1 in 1 KIT	09/15/2020	12/31/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	59 mL
Part 2	1 PATCH	5.5 mL

Part 1 of 2

BIOPURE ANTIBACTIAL GEL HAND SANITIZER 
alcohol gel

Product Information
Item Code (Source)	NDC: 78691-006
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78691-006-00	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/15/2020	12/31/2022

Part 2 of 2

ALCOHOL 
biopure antibactial hand wipe single pack patch

Product Information
Item Code (Source)	NDC: 78691-007
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: 78691-007-00	1 in 1 POUCH
1		5.5 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 not final	part333E	09/15/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/15/2020	12/31/2022

Labeler - QUEST USA CORP. (079869689)

Revised: 1/2023

Document Id: f305d354-1be6-6f76-e053-2995a90ac091

34390-5

Set id: ad2af46c-725d-2490-e053-2a95a90a5043

Version: 3

Effective Time: 20230124