Label: ANTIBACTERIAL WET 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 January 8, 2018

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  • Active ingredient

    Benzalkonium chloride 0.1%

    Purpose

    Antibacterial

  • Use

    Use decreases bacteria on skin.

  • Warnings

    For external use only.

    Do not use over large areas of the body if you are allergic to any of the ingredients.

    When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

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

    Keep out of reach of children. If swallowed, get medical help or contact a PoisonControlCenterright away.

    Keep out of reach of children

    Keep out of reach of children. If swallowed, get

    medical help or contact aPoisonControlCenter

    right away.

  • Directions

    For adults and children of 2 years and over use on hands and face to clean and refresh, allow skin to air dry.

    For children under 2 years ask a doctor before use.

  • INACTIVE INGREDIENT

    water, propylene glycol, cocamidopropyl betaine, polyaminopropyl biguanide, glycine, disodium EDTA, aloe barbadensis leaf extract, tocopheryl acetate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, PEG-40 hydrogenated castor oil.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42255-587
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    GLYCINE (UNII: TE7660XO1C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42255-587-013 in 1 BAG01/08/2018
    110 in 1 PACKAGE
    12.75 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:42255-587-0220 in 1 BAG01/08/2018
    21 in 1 PACKAGE
    23 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 finalpart333A01/17/2013
    Labeler - ZHEJIANG GREENFACE HOUSEWARES CO., LTD. (546596567)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG GREENFACE HOUSEWARES CO., LTD.527999264manufacture(42255-587)
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