Label: ANTIBACTERIAL MOIST WIPES- benzalkonium chloride swab

  • 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 May 4, 2015

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  • Active ingredient

    Benzalkonium chloride  0.1%

  • Purpose

    antibacterial

  • Use

    decreases bacteria on skin

  • Warnings

    for external use only

    over large areas of the body 

    if you are allergic to ay of the ingredients

    When using this product avoid contact with eyes and face.

    if contact occurs,flush throughly with water


    stop use and ask a doctor uf 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 Poison Control Center right away.

  • Directions

    for adults and children of 2 years and over.

    children under 2 years ask a doctor before use

    allow to dry without wiping

  • INACTIVE INGREDIENT

    water ,sodium lauryl sulfate,fragrance,2-bromo-2-nitropropane-1,3-diol,aloe barbadensis leaf extract,disodium EDTA,triethanolamine,glycerin,tocopheryl acetate.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL MOIST WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69733-558
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    2-BROMO-2-NITROETHANOL (UNII: FA22WV2B2Z)  
    2-METHYL-2-PROPYLPROPANE-1,3-DIOL (UNII: YLM5KRU0P4)  
    ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69733-558-0220 in 1 PACKAGE
    10.00297 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 finalpart333E04/15/2015
    Labeler - JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD (421340473)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD421340473manufacture(69733-558)
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