Label: PREMIUM PROTECTION ANTIBACTERIAL HAND- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • 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, 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 Posion Control Center immediately

  • Directions

    Apply to wet hands. Work into a latther and rinse thoroughly. Children under 6 years of age should be supervised when using this product.

  • Inactive Ingredients

    Water, Cocamidopropyl Betaine, PEG 150 Distearate, Caprylyl Glucoside, Glycerine, Cocamide MIPA, Tetrasodium EDTA, Fragrance, Citric Acid, Aloe Vera, Benzisothiazol, Methylisothiozol, Yellow #5, Red #40

  • Premium Protection Antibacterial Hand Soap

    Premium Protection Antibacterial Hand Soapimage description

  • INGREDIENTS AND APPEARANCE
    PREMIUM PROTECTION ANTIBACTERIAL HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77617-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    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:77617-002-024 in 1 BOX04/15/2018
    1NDC:77617-002-013.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM04/15/2018
    Labeler - Maintex (008317307)
    Registrant - Maintex (008317307)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc DBA Custom Chemical Formulators Inc028311595manufacture(77617-002) , api manufacture(77617-002) , pack(77617-002)
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