Label: JANITEX ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

  • 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 14, 2020

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride (0.2%)

  • Purpose

    Antiseptic

  • Uses

    ● For hand sanitizing to decrease bacteria and germs on skin.

    ● Apply topically to the skin to help prevent cross contamination.

    ● Not Recommended for repeated use.

    ● Dries in seconds.

  • Warnings

    • For external use only. Harmful if swallowed.

    • Do not use as baby wipes.

    • Do not use in or contact the eyes.

    Avoid contact with open or exposed wounds.

    When Using

    Keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water

    Stop Use

    Stop use if too much skin irritation and sensitivity develops or increases

    KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    ● Open lid, gently peel back resealable label, remove and use wipes as required

    ● Reseal after use to avoid evaporation of alcohol it is a violation of federal law to use this product in

    a manner inconsistent with its labeling.

  • Other Informations

    • Store at room temperature 15-30℃ (59-86°F).

    • Lot No. Manufacture date and expiration date can be found on package.

  • Inactive Ingredients

    Aqua, Olus Oil, Glycerin, Lauryl Glucoside, Polyglyceryl-2- Dipolihydroxystearate, Glyceryl Oleate,

    Dicapiryl Carbonate, Perfume, Triethanolamine

  • SPL UNCLASSIFIED SECTION

    Kills 99.9% Bacteria & Germs

    ANTIBACTERIAL

    ANTI - FUNGAL

    pH 5.5

    BLEACH FREE

    Made in Turkey

    Distributed by Pacific Health Systems Inc.

    19 Commerce Road Unit E Fairfield, NJ 07004

    info@janitexus.com    www.janitexus.com

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    JANITEX ANTIBACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79519-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79519-010-0172 in 1 CARTON06/30/2020
    14.16 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:79519-010-0280 in 1 CARTON06/30/2020
    24.16 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:79519-010-03100 in 1 CARTON06/30/2020
    34.16 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/2020
    Labeler - Pacific Health Systems Inc. (080638960)
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