B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13% (BENZALKONIUM CHLORIDE) GEL [MIDWAY ADVANCED PRODUCTS LLC]

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  • B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13% (BENZALKONIUM CHLORIDE) GEL [MIDWAY ADVANCED PRODUCTS LLC]

B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13% (BENZALKONIUM CHLORIDE) GEL [MIDWAY ADVANCED PRODUCTS LLC]
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NDC 52490-500-01, 52490-500-15, 52490-500-16, 52490-500-20, 52490-500-21, 52490-500-31
Set ID f7bba189-ac8e-4d97-a869-8ad40bdc7cd1
Category HUMAN OTC DRUG LABEL
Packager Midway Advanced Products LLC
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on the skin.

  • Warnings

    ​For external use only

    ​Do not use​

    • in the eyes

    ​Stop use and ask a doctor if

    • irritation and redness develop
    • if condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping

  • Other information

    store at room temperature

  • Inactive ingredients

    butylene glycol, caesalpinia spinosa gum, citric acid, ethylhexylgycerin, fragrance, glycerin, phenoxyethanol, sodium lauryl sulfate, water

  • Package Labeling:

    52490-500-15 label

    52490-500-20 label

    52490-500-01 label

    52490-500-16 label

    52490-500-21 label

    52490-500-31 label

  • INGREDIENTS AND APPEARANCE
    B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13% 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52490-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52490-500-1515 mL in 1 TUBE; Type 0: Not a Combination Product05/15/201706/13/2020
    2NDC:52490-500-20500 in 1 CARTON05/15/201706/13/2020
    215 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:52490-500-010.7 mL in 1 PACKAGE; Type 0: Not a Combination Product02/01/201807/13/2020
    4NDC:52490-500-16100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/201802/05/2020
    5NDC:52490-500-21100 in 1 CARTON02/01/201802/05/2020
    5100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:52490-500-312000 in 1 CARTON02/01/201806/08/2020
    60.7 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/15/201707/13/2020
    Labeler - Midway Advanced Products LLC (962765009)
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