BYD Antibacterial Wet Wipes (Children) by BYD Automative Industry Co., Ltd.

BYD Antibacterial Wet Wipes (Children) by

Drug Labeling and Warnings

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

Drug Details [pdf]

BYD ANTIBACTERIAL WET WIPES (CHILDREN)- disinfectant wipes cloth 
BYD Automative 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.

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

Made in China

Distributed by Global Healthcare Product Solutions, LLC

1 (800) 293-2886

Active Ingredient:

Benzalkonium Chloride 0.13% (w/w)

Purpose:

Antibacterial

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 Posion 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:

For dispensing, peel back front label at tab. Remove wipes as needed. Reseal pouch by pressing label firmly back into place.

Inactive ingredients:

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

Package Label - Principal Display Panel

BYD ANTIBACTERIAL WET WIPES (CHILDREN) 
disinfectant wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75035-006
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
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
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.03 g  in 100 g

Product Characteristics
Color	pink (Package Color)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75035-006-01	25 g in 1 BAG; Type 1: Convenience Kit of Co-Package	08/12/2020	10/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/12/2020	10/01/2022

BYD ANTIBACTERIAL WET WIPES (CHILDREN) 
disinfectant wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75035-005
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
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
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.03 g  in 100 g

Product Characteristics
Color	blue (Package Color)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75035-005-01	25 g in 1 BAG; Type 1: Convenience Kit of Co-Package	08/12/2020	10/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/12/2020	10/01/2022

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

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

Establishment
Name	Address	ID/FEI	Business Operations
BYD Automative Industry Co., Ltd.		545351723	manufacture(75035-005, 75035-006) , label(75035-005, 75035-006) , pack(75035-005, 75035-006)

Revised: 7/2023

Document Id: ffb0b3cd-9675-9e98-e053-6394a90a7b0b

34390-5

Set id: acb25df3-679f-af77-e053-2995a90ab6fd

Version: 2

Effective Time: 20230704