Label: ANTIBACTERIAL WIPES- benzalkonium chloride cloth

  • NDC Code(s): 81079-001-01, 81079-001-02, 81079-001-03, 81079-001-04, view more
    81079-001-05, 81079-001-06
  • Packager: SHAOXING ELITE BIO-TECH CO.,LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 22, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient(s)

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial Agent

  • Use

    Decreases bacteria on 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 and mouth. lf product gets in the eyes, flush thoroughly with water.

  • STOP USE

    Discontinue use and contact a doctor if irritation and redness develop and condition persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Tear open the packet and remove wipe.

    Wet hands thoroughly with product and let hands air dry.

    Throw used wipe in trash.

    Do not flush.

  • Other information

    Adults and children 2 years and over. Apply to hands. Allow skin to dry without Wiping.

    Children under 2 years. Consult a doctor prior to use.

  • Inactive ingredients

    C12-14 Alkyl Dimethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene Glycol, Vitamin E, Aloe Barbadensis Leaf Juice, Aqua.

  • Antibacterial Wipes Package Label

    NDC:81079-001-01

    10

    NDC:81079-001-02

    20

    ​NDC:81079-001-03

    40

    ​NDC:81079-001-04

    60

    ​NDC:81079-001-05

    80

    ​NDC:81079-001-06

    100

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81079-001
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81079-001-0138 g in 1 BAG; Type 0: Not a Combination Product11/15/2020
    2NDC:81079-001-0276 g in 1 BAG; Type 0: Not a Combination Product11/15/2020
    3NDC:81079-001-03153 g in 1 BAG; Type 0: Not a Combination Product11/15/2020
    4NDC:81079-001-04230 g in 1 BAG; Type 0: Not a Combination Product11/16/2020
    5NDC:81079-001-05307 g in 1 BAG; Type 0: Not a Combination Product11/16/2020
    6NDC:81079-001-06384 g in 1 BAG; Type 0: Not a Combination Product11/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/15/2020
    Labeler - SHAOXING ELITE BIO-TECH CO.,LTD. (546459425)
    Registrant - SHAOXING ELITE BIO-TECH CO.,LTD. (546459425)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHAOXING ELITE BIO-TECH CO.,LTD.546459425manufacture(81079-001)
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