Label: STRIKE BAC ANTIBACTERIAL HAND- benzalkonium chloride liquid

  • NDC Code(s): 62569-981-01, 62569-981-02, 62569-981-16, 62569-981-17
  • Packager: Genlabs Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 12, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Benzalkonium Chloride........0.13%

  • Purpose

    Antiseptic

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

  • When Using this Product

    Avoid contact with the eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops

    or if condition persist for more than 72 hours.

  • Keep out of reach of children.

    If swallowed, get medical help

    or contact Posion Control Center right away.

  • Directions

    -Pump into hands, wet as needed.

    -Lather skin Vigorously for at least 15 seconds.

    -Wash skin, rinse thoroughly and dry.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Caprylyl/Capryl Glucoside, Citric Acid, Cocamide MIPA, Cocamidopropyl Betaine, Fragrance, Glycerin, Lauryl Polyglucose, Magnesium Nitrate, Maltodextrin, Methylchloroisothiazolinone, Methylisothiazolinone, PEG 150 Distearate, FD&C Red #40, Tetrasodium EDTA, Water, FD&C Yellow #5

  • Strike Bac Antibacterial Hand Soap

    image description

  • Strike Bac Antibacterial Hand Soap

    image description

  • INGREDIENTS AND APPEARANCE
    STRIKE BAC ANTIBACTERIAL HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62569-981
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.13 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62569-981-021 in 1 BOX12/14/2023
    1NDC:62569-981-013.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:62569-981-171 in 1 BOX12/14/2023
    2NDC:62569-981-16.0568 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/14/2023
    Labeler - Genlabs Corporation (064594260)
    Registrant - Genlabs Corporation (064594260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.028311595manufacture(62569-981) , api manufacture(62569-981) , pack(62569-981)