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 November 12, 2012

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  • Active Ingredient

    Benzalkonium Chloride

    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.
    Keep out of eyes,Incase of contact,rinse with water.If irritation or rash develops,discontinue use .Consult doctor if irritation persists for more than 72 hours,If swallowed,seek medical attention or contact a Poison Control Center.

    keep out of reach of children

    keep out of reach of children

  • Directions

    Open resealable label.Pull one sheet from pack.Clean hands or affected area and discard.Re-seal label after each use to keep wipes fresh.

  • Inactive ingredients

    Iodopropynyl Butylcarbamate,DMDM Hydantoin,Lauryl Glucoside,Glycerin,D-Panthenol,Tocopheryl Acetate,Chamomilla Recutita Extract,PEG-12 Dimethicone,Disodium EDTA,Aloe Barbadensis Leaf Extract,Allantoin,Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50672-838
    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)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Lauryl Glucoside (UNII: 76LN7P7UCU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Allantoin (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50672-838-013.3 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/12/2012
    Labeler - MC Group Development Ltd. (527868588)
    Establishment
    NameAddressID/FEIBusiness Operations
    MC Group Development Ltd.527868588manufacture(50672-838)
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