Label: ANTISEPTIC LIQUID- benzalkonium chloride soap

  • Contains inactivated NDC Code(s)
    NDC Code(s):     79392-102-01, 79392-102-02, 79392-102-03, 79392-102-04, view more
    79392-102-05, 79392-102-06, 79392-102-07, 79392-102-08, 79392-102-09, 79392-102-10, 79392-102-11, 79392-102-12, 79392-102-13, 79392-102-14, 79392-102-15, 79392-102-16, 79392-102-17, 79392-102-18
  • Packager: ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
  • 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 July 20, 2020

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  • Drug Facts

  • Active ingredient 

    0,5% (w/w) Benzalkonium Chloride

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use

  • Warnings

    For external use only

    Do not use

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

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
    Stop use and ask a doctor if
    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Squeeze a few pumps into your palms, foam with water and rinse.
    • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    Deionised Water, Cocamidopropyl Betaine, Sodium Cocoamphoacetate, Lauryl Glucoside, Glycerin, PEG-150 Distearate, Hydrogenated Castor Oil,
    Sodium Chloride, Citric Acid, CI 42090

  • Questions?

    +1-646-301-0044
    You may also report serious side effects to this phone number.

    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Itimat Kozmetik Urunleri San. Ve Tic. A.S.
    Karadeniz District. M.Akif Avenue 1117/1 Street No:8
    Gaziosmanpasa / ISTANBUL
    COUNTRY OF ORIGIN: TURKEY
    Batch No:

    Expiry:

    www.fonex.com.tr - info@fonex.com.tr

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC LIQUID 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79392-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79392-102-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    2NDC:79392-102-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    3NDC:79392-102-03150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    4NDC:79392-102-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    5NDC:79392-102-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    6NDC:79392-102-06750 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    7NDC:79392-102-071000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    8NDC:79392-102-081500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    9NDC:79392-102-092000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    10NDC:79392-102-102500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    11NDC:79392-102-113000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    12NDC:79392-102-123500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    13NDC:79392-102-134000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    14NDC:79392-102-144500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    15NDC:79392-102-155000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    16NDC:79392-102-1610000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    17NDC:79392-102-1720000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    18NDC:79392-102-1836 in 1 BOX07/20/2020
    1850 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/20/2020
    Labeler - ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (356579552)
    Establishment
    NameAddressID/FEIBusiness Operations
    ITIMAT KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI356579552manufacture(79392-102)
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