Label: ANTIBACTERIAL WET WIPES- benzalkonium chloride swab

  • Category: HUMAN OTC DRUG LABEL

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 0.115%

    Purpose

    Antibacterial

  • Use

    For hand washing to decrease bacteria on the skin.

    May be used on face, arms and legs.

  • Warnings

    For external use only.

    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

    Keep out of reach of children. If swallowed, get

    medical help or contact aPoisonControlCenter

    right away.

  • Directions

    For use apply thoroughly to hands and face as

    desired. Allow to dry without wiping.

    For dispensing lift tab at front of lid to open.

    Pull up corner of center sheet and thread through

    dispenser slit in lid. Pull out exposed wipe at a 45°

    angle and snap off. The next wipe is ready for

    dispensing. Close lid to retain moisture. Dispose

    of used wipes in trash receptacle. Do not flush.

  • INACTIVE INGREDIENT

    water, aloe barbadensis leaf extract, disodium

    cocoamphodiacetate, SD alcohol 40-B,

    methylchloroisothiazolinone,

    methylisothiazolinone, tocopheryl acetate,

    disodium EDTA, citric acid, fragrance

  • PRINCIPAL DISPLAY PANEL

    label60

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42255-586
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42255-586-0160 in 1 PACKAGE01/08/2018
    11.875 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 finalpart333A12/27/2012
    Labeler - ZHEJIANG GREENFACE HOUSEWARES CO., LTD. (546596567)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG GREENFACE HOUSEWARES CO., LTD.527999264manufacture(42255-586)
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