Label: AB 3000- benzalkonium chloride liquid

  • 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 November 23, 2021

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

  • ACTIVE INGREDIENT

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

  • Inactive Ingredients 

    Aloe Barbadensis Leaf Juice, Benzisothiazolinone, Caprylyl Glucoside, Citric Acid, Cocamide MIPA, Cocamidopropyl Betaine, Fragrance, Glycerine, Lauryl Glucoside, Maltodextrin, Methylisothiozolinone, PEG 150 Distearate, Red #40, Tetrasodium EDTA, Water, Yellow #5

  • Purpose

    Antibacterial

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

  • When Using this Product

    Avoid contact with eyes. If contat occurs, rinse eyes thoroughly with water.

    Do not ingest. Stop use and contact a doctor if irritation and 

    redness develop and conditions persist.

  • Keep out of reach of children.

    If swallowed, get medical help

    or contact Poison Control Center immediately.  

  • Directions

    - Apply to wet hands. Work into lather and rinse thoroughly.

    - Children under 6 years of age should be supervised when using this product.

  • AB 3000 Hand Soap

    AB 3000 Hand Soapimage description

  • INGREDIENTS AND APPEARANCE
    AB 3000 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63039-1006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63039-1006-21 in 1 BOX12/29/2020
    1NDC:63039-1006-13.80564 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 other12/29/2020
    Labeler - Chemco (063798714)
    Registrant - Chemco (063798714)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.028311595manufacture(63039-1006) , api manufacture(63039-1006) , pack(63039-1006)