Label: ANTIBACTERIAL HANDSOAP- benzalkonium chloride liquid

  • NDC Code(s): 68041-604-01, 68041-604-55
  • Packager: Chemcor Chemical 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 December 26, 2023

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

  • Active Ingredient

    Benzalkonium .13%

  • Purpose

    Antimicrobial

  • Uses

    • Handwash to help decrease bacteria on skin

    • Recommended for repeated use

  • Warnings

    For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands

    • Apply product and thoroughly cover all surfaces of both hands with lather

    • Rinse both hands well

    • Dry hands completely

  • 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

  • SPL UNCLASSIFIED SECTION

    moisturizes

    hard on germs

    tough on surface bacteria

    MAY BE HARMFUL IF SWALLOWED.

    MAY CAUSE IRRITATION TO EYES.

    SEE BACK PANEL FOR ADDITIONAL PRECAUTIONS AND FIRST AID.

    institutional & commercial antibacterial hand cleanser

    DESCRIPTION

    AN EFFECTIVE ANTIBACTERIAL LOTION HAND AND SKIN CLEANSER WHICH CONTAINS CHLOROXYLENOL, AN OUTSTANDING GERM FIGHTING INGREDIENT. FORMULATED TO BE TOUGH ON BACTERIA AND GERMS. REGULAR USE OF THIS ANTIBACTERIAL HAND SOAP HELPS DECREASE BACTERIA LEVELS ON THE SKIN AND HELPS REDUCE RISK OF INFECTIONS. PRODUCES RICH MOISTURIZING LATHER TO PROMOTE COMPLETE GENTLE CLEANSING. LEAVES THE SKIN CLEAN, SOFT AND REFRESHED. IDEAL FOR DISPENSING IN LIQUID SOAP PUMP DISPENSERS.

    Before discarding container, rinse with water.

    For institutional and commercial use.

  • Antibacterial Lotion Handsoap

    image description
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HANDSOAP 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68041-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.13 g  in .1 L
    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:68041-604-013.78 L in 1 BOTTLE; Type 0: Not a Combination Product02/02/2023
    2NDC:68041-604-55207.9 L in 1 DRUM; Type 0: Not a Combination Product02/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/02/2023
    Labeler - Chemcor Chemical Corporation (018129978)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.028311595manufacture(68041-604) , api manufacture(68041-604) , pack(68041-604)