Label: ANTIBACTERIAL WIPES- benzalkonium chloride cloth

  • NDC Code(s): 52489-002-01, 52489-002-02, 52489-002-03, 52489-002-04, view more
    52489-002-05, 52489-002-06, 52489-002-07, 52489-002-08, 52489-002-09
  • Packager: Imperial Palace Commodity (shenzhen) Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient(s)

    Benzalkonium chloride ：0.13% (W/W)

  • Purpose

    Antibacterial

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    For external use only.

  • Do not use

    Do not use if you are allergic to any of the ingredients.

  • WHEN USING

    When using this product avoid contact with eyes. In case of eye contact,flush thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children. If swallowed, get medical help or contact a Poision Control Center right away.

  • Directions

    Adults and children 6 years and over :

    Wet hands thoroughly with wipes and allow to dry, dispose of used wipe in trash, don not flush

    Children under 6 years:

    ask a doctor before use.

  • How to uses

    Packs

    ●Peel back lid and then label.

    ●Remove wipes as required.

    ●Replace lid and label to keep wipes moist.

    Buckets

    ●Open the bucket lid from the top.

    ●Locate tear cut in the inner pouch, tear straight to open. Do not remove wipesroll from pouch.

    ●Pull first wipes from center of roll up through opening.

    ●Thread first wipe through dispensing nozzle in top of roll.

    ●Close the bucket lid and dispense the wipes as required.

  • Inactive ingredients

    ●Water(Aqua)

    ●Cetylpyridinium chloride

    ●Chlorphenesin

    ●Ethylhexylglycerin

    ●Propylene glycol

    ●Glycerol

  • Package Label - Principal Display Panel

    NDC:52489-002-01

    label-80 wipes package

    NDC:52489-002-02

    label-100 wipes pail

    NDC:52489-002-03

    label-250 wipes inner package

    label-250 wipes external pail

    NDC:52489-002-04

    label-800 wipes inner package

    label-800 wipes external pail

    NDC:52489-002-05

    label-1 wipes 3NDC:52489-002-06

    label-1 wipe 4NDC:52489-002-07

    label-50 wipes packageNDC:52489-002-08

    label-60 wipes package

    NDC:52489-002-09

    label-1000

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52489-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    WATER (UNII: 059QF0KO0R)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52489-002-01360 mL in 1 PACKAGE; Type 0: Not a Combination Product05/27/2020
    2NDC:52489-002-02370 mL in 1 PAIL; Type 0: Not a Combination Product05/27/2020
    3NDC:52489-002-03940 mL in 1 PAIL; Type 0: Not a Combination Product05/27/2020
    4NDC:52489-002-043000 mL in 1 PAIL; Type 0: Not a Combination Product05/27/2020
    5NDC:52489-002-053.3 mL in 1 PACKAGE; Type 0: Not a Combination Product07/22/2020
    6NDC:52489-002-064.6 mL in 1 PACKAGE; Type 0: Not a Combination Product07/22/2020
    7NDC:52489-002-07230 mL in 1 PACKAGE; Type 0: Not a Combination Product07/22/2020
    8NDC:52489-002-08280 mL in 1 PACKAGE; Type 0: Not a Combination Product07/22/2020
    9NDC:52489-002-093560 mL in 1 PACKAGE; Type 0: Not a Combination Product09/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/27/2020
    Labeler - Imperial Palace Commodity (shenzhen) Co., Ltd (527796368)
    Registrant - Imperial Palace Commodity(Dongguan) CO.,LTD (544367643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Imperial Palace Commodity(Dongguan) CO.,LTD544367643manufacture(52489-002)
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