Label: BYD ANTIBACTERIAL WET WIPES (CHILDREN)- disinfectant wipes cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated September 20, 2020

If you are a consumer or patient please visit this version.

  • 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

    01_101_2

  • 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.

    10

  • Other information:

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

    11

  • Inactive ingredients:

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

    12

  • Package Label - Principal Display Panel

    13_113_2

  • INGREDIENTS AND APPEARANCE
    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)