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 August 11, 2020

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  • Drug Facts

  • Active Ingredients

    Benzalkonium Chloride (0.1%)

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin that could cause disease
  • Warnings

    • For external use only, harmful if swallowed.
    • Do not use as baby wipe.
    • Do not flush.
    • Do not use on open skin wounds.
    • Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
    • Stop use and ask a doctor if irritation or allergic reaction occurs.
    • Flammable - Keep away from fire or flame

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Open lid, gently peel back resealable label, remove and use wipes as required. Keep lid closed to prevent moisture loss.

    • No need to rinse after usage. Allow skin to dry without wiping. • For adults and children 2 years and over. Discard properly after use. • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

    • Store in dry and cool place and away from oxidizers.
  • Inactive ingredients

    Aqua, Phenoxyethanol, Propylene Glycol, Parfum, Cocamidopropyl Betaine, PEG-40 Hydrogenated Castor Oil, Benzoic Acid, Tetrasodium EDTA, Dehydroacetic Acid, Sodium Hydroxide

  • SPL UNCLASSIFIED SECTION

    pH 5.5

    E Vitamin

    DERMATOLOGICALLY TESTED 

    + moisturizer 

    non-woven fabric

    Bleach Free

    Ultra Protection

    ANTIBACTERIAL

    Distributed by Pacific Health Systems Inc.

    19 Commerce Road Unit E Fairfield, NJ 07004

    info@janitexus.com www.janitexus.com

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    JANITEX ANTIBACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79519-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79519-050-0190 in 1 PACKET08/11/2020
    13.23 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/11/2020
    Labeler - Pacific Health Systems Inc. (080638960)
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