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
  • 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 8, 2020

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

  • 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
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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 not finalpart333A05/27/2020
    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)