Biopure Sanitizing Alcohol Free Wipes by QUEST USA CORP / Zhangzhou Zhongnan Nursing Products Co.,Ltd.

Biopure Sanitizing Alcohol Free Wipes by

Drug Labeling and Warnings

Biopure Sanitizing Alcohol Free Wipes by is a Otc medication manufactured, distributed, or labeled by QUEST USA CORP, Zhangzhou Zhongnan Nursing Products Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOPURE SANITIZING ALCOHOL FREE WIPES- sanitizing wipes liquid 
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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Active Ingredient(s)

Benzalkonium Chloride 0.12%

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria on the skin

Warnings

For external use only. Flammable. keep away from fire or flame.

Do not use

• In children less than 2 months of age
• On open skin wounds

When using this product

When using this product do not get in eyes. If contact is made rinse thoroughly with water.

Stop use and ask a doctor if

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children

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

Directions

• Wet hands thoroughly with product and allow to dry.
• Children under 6 years of age should be supervised when using BIOPURE products.

Inactive Ingredients

Water (Aqua), Decyl Glucoside, Phenoxyethanol, Glycerin, Fragrance (Parfum)

Package Label - Principal Display Panel

1600 Wipes; NDC - 78691-697-16

BIOPURE SANITIZING ALCOHOL FREE WIPES 
sanitizing wipes liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78691-697
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78691-697-16	4500 g in 1 BAG; Type 0: Not a Combination Product	06/09/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/09/2020	12/31/2022

Labeler - QUEST USA CORP (079869689)

Establishment
Name	Address	ID/FEI	Business Operations
Zhangzhou Zhongnan Nursing Products Co.,Ltd.		416376835	manufacture(78691-697)

Revised: 12/2022

Document Id: f0e5874f-6458-05ac-e053-2a95a90a2b04

34390-5

Set id: a7ab3f85-143d-bc41-e053-2a95a90a42c0

Version: 2

Effective Time: 20221228