Label: BIOORBIL ANTIBACTERIAL HANDSOAP- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 11, 2021

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  • Identity

    BioOrbil ANTIBACTERIAL HAND SOAP

    Identity

  • Active lngredient(s)

    Benzalkonium Chloride 0.13%

    Active Ingredient(s)

  • Purpose

    Antimicrobial

    Purpose

  • Use(s)

    For hand washing to help reduce bacteria and germs on the skin.

    Use(s)

  • Warnings

    • For external use only.
    • Not edible. Don' t drink.
    • Prolonged skin contact may cause temporary irritation.

    ​Warnings

  • DO NOT USE

    • in children less than 2 months of age.
    • on open skin wounds.

    DO NOT USE

  • When using this product

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    When using this product

  • Stop use and ask a doctor

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Stop use and ask a doctor

  • Keep out of reach of children

  • Direction

    • Pump into hands,wet as needed.
    • Lather vigorously for at least 15 seconds.
    • Wash hands, rinse thoroughly and dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

    Direction

  • Other Information

    Store between 59-86°F (15-30°C). Avoid freezing and excessive heat above 104°F(40°C). May discolor certain fabrics and surfaces.

    Other Information

  • Inactive Ingredients

    Aqua, Cocamidopropyl Betaine, Coco-Glucoside, Glycerin, Peg 150 Distearate, Cocomide MIPA, Sodium Benzoate, Polyquaternium 7, Disodium EDTA, Lime Oil, Phenoxyethanol, Citric Acid, Tocopheryl Acetate, Panthenol.

    Inactive Ingredients

  • Dosage and Administration

    Dosage and Administration

  • Usage Section

    Usage Section

  • Packaging

    INSTANT EFFECT-PLUS FORMULA

    Clean,Sanitize and Moisture

    Free of paraben, dye and phthalates

    ANTIBACTERIAL LIQUID SOAP

    - Sanitizing formula to help reduce cross-contamination

    - Hands feel smooth, soft and refreshed

    Distributed by

    PBITTS LLC

    836 Foster Ave Bensenville

    ILLINOIS 60106

    Manufacturing Company

    Asilnur Gıda ve Kimya San. Tic. Ltd. Şti.

    formulated by: Aziz Aydın

    MADE IN TURKEY

    Packaging

    Packaging

  • INGREDIENTS AND APPEARANCE
    BIOORBIL ANTIBACTERIAL HANDSOAP 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81396-101
    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
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LIME OIL (UNII: UZH29XGA8G)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLIMEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81396-101-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/31/2021
    Labeler - ASILNUR GIDA VE KIMYA SANAYI TICARET LIMITED SIRKETI (503002931)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASILNUR GIDA VE KIMYA SANAYI TICARET LIMITED SIRKETI503002931manufacture(81396-101)
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