Label: ANTIBACTERIAL WET WIPES- benzalkonium chloride swab 

  • NDC Code(s): 42255-586-01
  • Packager: ZHEJIANG GREENFACE HOUSEWARES CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzalkonium chloride 0.115%

    Purpose

    Antibacterial

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  • Use

    For hand washing to decrease bacteria on the skin.

    May be used on face, arms and legs.

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  • 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.

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  • 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.

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  • INACTIVE INGREDIENT

    water, aloe barbadensis leaf extract, disodium

    cocoamphodiacetate, SD alcohol 40-B,

    methylchloroisothiazolinone,

    methylisothiazolinone, tocopheryl acetate,

    disodium EDTA, citric acid, fragrance

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42255-586
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.115 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    DISODIUM COCOAMPHODIACETATE  
    ALCOHOL  
    methylchloroisothiazolinone  
    methylisothiazolinone  
    .ALPHA.-TOCOPHEROL ACETATE  
    DISODIUM EDTA-COPPER  
    CITRIC ACID ACETATE  
    ALOE VERA LEAF  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42255-586-01 60 in 1 PACKAGE
    1 1.875 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333A 12/27/2012
    Labeler - ZHEJIANG GREENFACE HOUSEWARES CO., LTD. (546596567)
    Establishment
    Name Address ID/FEI Business Operations
    ZHEJIANG GREENFACE HOUSEWARES CO., LTD. 546596567 manufacture(42255-586)
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