ANTIBACTERIAL WIPES patch

Antibacterial Wipes by

Drug Labeling and Warnings

Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by Fujian Yifa Healthcare Products Co., Ltd., A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride, 0.15% w/w;

Didecyldimonium Chloride, 0.2% w/w.

Inactive ingredient

Phenoxyethanol, Propylene Glycol, Glycerin, Water.

Purpose

Kill germs of staphylococcus aureus, candida albicans and escherichia coli.

When using

Antibacterial for hands, medical devices, medical supplies and the surface of articles.

Do not use

• on children less than 2 months of age
• on open skin wounds

Stop use

Stop to use immediately if having a negative impact on the objects and flush with water.

Keep out of reach of children

Keep out of reach of children.

Indications & usage

Skin’s cleaning care, Article surface’s cleaning and maintenance.

Remove seal, pull out sheet and wipe skin or articles.

(For external use only)

Dosage & administration

Use it as needed, after following the usage instructions.

For external use only.

Warnings

• Discard immediately after use, and cover the lid in time.
• Follow the principle” One wipe to one article” to avoid cross-infection.
• Avoid contact with eyes. If contact occurs, immediately flush with water.
• External use Prohibit internal use.
• Be sure to wear gloves when having hand cut or be allergic to wipes.

Package label. Principal display panel

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WIPES 
antibacterial wipes patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75543-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.15 U  in 100 U
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.2 U  in 100 U

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75543-201-18	100 in 1 PACKAGE	05/05/2020
1	NDC: 75543-201-01	1 U 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 not final	part333A	05/05/2020

Labeler - Fujian Yifa Healthcare Products Co., Ltd. (420510793)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Fujian Yifa Healthcare Products Co., Ltd.		420510793	label(75543-201) , manufacture(75543-201)