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]
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NDC 52490-500-01, 52490-500-16, 52490-500-21, 52490-500-31
Set ID f39d7373-1742-49cc-986c-9bb95955b847
Category HUMAN OTC DRUG LABEL
Packager Midway Advanced Products LLC
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • 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
    • condition persists 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

    • wet hands thoroughly with product
    • allow to dry without wiping
  • Other information

    • store at room temperature
  • Inactive ingredients

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

  • Hand Sanitizer 0.7 mL

    52490-500-01

  • Hand Sanitizer 100 mL

    52490-500-16

  • Hand Sanitizer 100 mL; 100 Ct

    52490-500-21

  • Hand Sanitizer 1400 mL, 2000 Ct

    52490-500-31

  • 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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52490-500-010.7 mL in 1 PACKAGE; Type 0: Not a Combination Product02/01/2018
    2NDC:52490-500-16100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    3NDC:52490-500-21100 in 1 CARTON02/01/2018
    3100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:52490-500-312000 in 1 CARTON02/01/2018
    40.7 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 finalpart333E02/01/2018
    Labeler - Midway Advanced Products LLC (962765009)
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