Label: ANTIBACTERIAL HAND SANITIZING 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 December 3, 2014

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  • active ingredient

    benzalkonium chloride 0.115%

    antibacterial

  • Use

    hand sanitizing to decrease bacteria on the 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 useing this product do not get in eyes. if contact occurs ,rinse throughly with water.

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

    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 use on hands,and face to clean and fresh,allow skin to air dry.

    for children under 2 years ask a dcotor before use.

  • INACTIVE INGREDIENT

    water,glycerol,propylene glycol,non-weven fabrics,coconut oil

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZING WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69425-001
    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)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69425-001-011 in 1 BAG
    10.00828 g in 1 POUCH
    2NDC:69425-001-022 in 1 BAG
    20.00828 g in 1 POUCH
    3NDC:69425-001-033 in 1 BAG
    30.00828 g in 1 POUCH
    4NDC:69425-001-045 in 1 BAG
    40.00828 g in 1 POUCH
    5NDC:69425-001-058 in 1 BAG
    50.00828 g in 1 POUCH
    6NDC:69425-001-0610 in 1 BAG
    60.00828 g in 1 POUCH
    7NDC:69425-001-0715 in 1 BAG
    70.00828 g in 1 POUCH
    8NDC:69425-001-0820 in 1 BAG
    80.00828 g in 1 POUCH
    9NDC:69425-001-0930 in 1 BAG
    90.00828 g in 1 POUCH
    10NDC:69425-001-1080 in 1 BAG
    100.00828 g in 1 POUCH
    11NDC:69425-001-11100 in 1 BAG
    110.00828 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/03/2014
    Labeler - Wuhan Bright Paper Factory (529575810)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wuhan Bright Paper Factory526890634manufacture(69425-001)