BYD Antibacterial Wet Wipes by BYD Automotive Industry Co., Ltd.

BYD Antibacterial Wet Wipes by

Drug Labeling and Warnings

BYD Antibacterial Wet Wipes by is a Otc medication manufactured, distributed, or labeled by BYD Automotive Industry Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BYD ANTIBACTERIAL WET WIPES- antiseptic wipes cloth 
BYD Automotive Industry 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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Misc.

Model: BZ-01

Manufactured by:

BYD Auto Industry Company Limited

No. 3001, 3007, Hengping Road, Pingshan, Shenzhen, 518118, P.R. China

Tel: +86-755-89888888

Website: www.byd.com

Distributed by Global Healthcare Product Solutions, LLC

1 (800) 293-2886

Made in China

Active Ingredient:

Benzalkonium Chloride 0.13% (w/w)

Purpose:

Antiseptic

Uses:

For hand washing to decrease bacteria on the skin.

Warnings:

For external use only

When using this product:

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

When using this product:

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor if:

Irritation or redness develops.

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.

For children under 6, use only under adult supervision.

Other information:

After opening, close the lid tightly to keep the wipes from drying out.

Inactive ingredients:

Decyl glucoside, glycerin, methylparaben, propylparaben, phenoxyethanol, tocopheryl acetate, water.

Package Label - Principal Display Panel

BYD ANTIBACTERIAL WET WIPES 
antiseptic wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75035-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.03 g  in 100 g
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)	0.25 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T)	0.1 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2 g  in 100 g
WATER (UNII: 059QF0KO0R)	96.39 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.1 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75035-021-01	100 g in 1 CAN; Type 1: Convenience Kit of Co-Package	06/15/2021	10/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2021	10/01/2022

Labeler - BYD Automotive Industry Co., Ltd. (545351723)

Registrant - BYD Automotive Industry Co., Ltd. (545351723)

Establishment
Name	Address	ID/FEI	Business Operations
BYD Automotive Industry Co., Ltd.		545351723	manufacture(75035-021) , label(75035-021) , pack(75035-021)

Revised: 7/2023

Document Id: ffaeb449-790e-090b-e053-6294a90a5e78

34390-5

Set id: c4d42bf4-3c93-d148-e053-2995a90ad73d

Version: 4

Effective Time: 20230704