Label: ANTIBACTERIAL HAND WIPES- benzalkonium chloride 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 June 22, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13 %

    Purpose

    Antimicrobial Agent

  • USE

    Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap
    and water are not available.

  • Warning

    For external use only. Do not use:
    ●In children less than 2 months of age.
    ●On open skin wounds.
    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes,
    rinse eyes thoroughly with water.
    Stop use and ask a doctor if iritation or rash occurs. These may be signs of a serious
    condition.

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

  • Directions

    Apply to hands, allow to dry without wiping. .

  • Inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78870-901
    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
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78870-901-0180 in 1 BAG06/23/2020
    1420 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:78870-901-0215 in 1 BAG06/23/2020
    282 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2020
    Labeler - AMERICAN EXCHANGE TIME LLC (830332164)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kangna (Zhejiang) Medical Supplies Co., Ltd.554530173manufacture(78870-901)
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