Label: ANTIBACTERIAL HAND SANITIZER- benzalkonium chloride gel

  • 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 6, 2018

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  • Active Ingredient

    Benzalkonium chloride 0.1%

    Purpose

    Antispetic

  • Use

    for hand washing to decrease bacteria on skin

  • WARNINGS

    For External use only-hands.

    Avoid contact with eyes,in case of contact ,flush with water.

    Keep out of direct sunlight

    do not drink,not edible

    keep out of reach of children

    keep out of reach of children

  • Directions

    press pump down to dispense liquid hand soap onto moistened hands,lather and rinse thoroughly

  • Inactive ingredients

    aqua ,sodium laureth sulfate,cocamidopropyl betaine,disodium cocoamphodiacetate,cocamide MEDA,Glycerin,Aloe Barbadensis leaf juice,PEG-7 glyceryl cocoate,sodium chloride,citric acid ,disodium EDTA,tocopheryl acetate,methylisothiazolinone,lodopropynyl butylcarbamate

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61312-007
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    COCAMIDE (UNII: 3YXD33R71G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61312-007-0124 in 1 CARTON10/23/2016
    1221 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/27/2014
    Labeler - Hangzhou Guoguang Touring Commodity Co., Ltd. (526890634)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Guoguang Touring Commodity Co., Ltd.526890634manufacture(61312-007)
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