Antibacterial wipes by Zhejiang Meizhiyuan Cosmetics Co.,Ltd

Antibacterial wipes by

Drug Labeling and Warnings

Antibacterial wipes by is a Otc medication manufactured, distributed, or labeled by Zhejiang Meizhiyuan Cosmetics Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL WIPES- benzalkonium chloride cloth 
Zhejiang Meizhiyuan Cosmetics Co.,Ltd

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

Benzalkonium chloride 0.13% w/v

Purpose

Antibacteria

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.
When using this product do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

Wet hands thorough Illy with produce and allow to dry.
Discard wipes in trash receptacle after use. Do not flush.
Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Water, Glycerin, Ethylhexylglycerin, Phenoxyethanol, Didecyldimonium chloride, alcohol, Propylene glycol.

Package Label - Principal Display Panel

ANTIBACTERIAL WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80204-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80204-035-01	80 in 1 PACKAGE	08/28/2020
1		4.41 mL in 1 CONTAINER; 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	part333A	08/28/2020	03/24/2024

Labeler - Zhejiang Meizhiyuan Cosmetics Co.,Ltd (543036597)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Meizhiyuan Cosmetics Co.,Ltd		543036597	manufacture(80204-035)

Revised: 12/2022

Document Id: 9612a593-4cec-4e18-a491-6b2966f226bd

34390-5

Set id: 5ad82db0-786c-4055-86c3-80d4894044b1

Version: 5

Effective Time: 20221203