BIOPURE ANTIBACTERIAL HAND WIPES- benzalkonium chloride patch

BIOPURE ANTIBACTERIAL HAND WIPES by

Drug Labeling and Warnings

BIOPURE ANTIBACTERIAL HAND WIPES by is a Otc medication manufactured, distributed, or labeled by Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.12 %

Purpose

Antibacterial

Uses

●Hand sanitizer to help reduce bacteria.

●For use when soap and water are not available.

Warnings

For external use only.

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.

●Avoid freezing and excessive heat.

Inactive ingredients

Water, Glycerin, Propylene Glycol, Ethylhexylglycerin, Phenoxyethanol, Didecyldimonium Chloride

79794-113

79794-113-01

INGREDIENTS AND APPEARANCE

BIOPURE ANTIBACTERIAL HAND WIPES 
benzalkonium chloride patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79794-113
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
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79794-113-01	12 in 1 CARTON	09/30/2024
1		72 in 1 POUCH
1		8.1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/30/2024

Labeler - Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. (723796509)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.		723796509	manufacture(79794-113)