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

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Active Ingredient:

Benzalkonium Chloride 0.13% (w/w)

02

Purpose:

Antibacterial

03

Uses:

For hand washing to decrease bacteria on the skin.

04

Warnings:

For external use only

05

When using this product:

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

06

When using this product:

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

07

Stop use and ask a doctor if:

Irritation or redness develops.

08

Keep out of reach of children:

If swallowed, get medical help right away.

09

Directions:

Wet hands thoroughly with product and allow to dry.

For children under 6, use only under adult supervision.

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Other information:

After unseal, tighten the cap and use product within the validity period.

11

Inactive ingredients:

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

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Package Label - Principal Display Panel

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BYD ANTIBACTERIAL WET WIPES (CHILDREN) 
disinfectant wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75035-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 0.5 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) 96.17 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.1 g  in 100 g
Product Characteristics
Colorgreen (Package Color) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75035-010-0130 g in 1 BAG; Type 1: Convenience Kit of Co-Package09/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/20/2020
BYD ANTIBACTERIAL WET WIPES (CHILDREN) 
disinfectant wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75035-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 0.5 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) 96.17 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.1 g  in 100 g
Product Characteristics
Colorpink (Package Color) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75035-009-0130 g in 1 BAG; Type 1: Convenience Kit of Co-Package09/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/20/2020
Labeler - BYD Automative Industry Co., Ltd. (545351723)
Registrant - BYD Automative Industry Co., Ltd. (545351723)
Establishment
NameAddressID/FEIBusiness Operations
BYD Automative Industry Co., Ltd.545351723manufacture(75035-009, 75035-010) , label(75035-009, 75035-010) , pack(75035-009, 75035-010)

Revised: 9/2020
Document Id: afc83432-8fd6-6d2a-e053-2a95a90ae73f
Set id: afc83ddc-d2ce-1bbc-e053-2995a90a2b89
Version: 1
Effective Time: 20200920
 
BYD Automative Industry Co., Ltd.