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 September 18, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.1 %

  • Purpose

    Antiseptic Hand Cleanser

  • Uses

    Kills harmful germs

  • Warnings

    • For external use only. Harmful if swallowed.
    • When using this product, avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
    • Stop use and ask a doctor if irritation develops.

    • Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

  • Directions

    • Adults and children over 2 years old
    • For occasional and personal domestic use
    • Supervise children when they use this product
    • Rub thoroughly into hands for at least 30 seconds. Allow to dry

  • Inactive Ingredients

    Aqua, Sodium Benzoate, Phenoxyethanol, Parfum, Benzoic Acid, Dehydroacetic Acid, Panthenol, Sodium Cocoamphoacetate, Sodium Lauriminodipropionate, Octyldodecanol

  • Other Informations

    Store in a cool & dry place

  • Questions?

    +1 (862) 318-4763

  • SPL UNCLASSIFIED SECTION

    ANTIBACTERIAL

    Ultra Protection

    pH 5.5

    E Vitamin

    DERMATOLOGICALLY TESTED

    + Moisturizer

    Non-Woven Fabric

    Bleach Free

    Distributed by Pacific Health Systems Inc.

    19 Commerce Road Unit E Fairfield, NJ 07004

    info@janitexus.com www.janitexus.com

    STORAGE AND DISPOSAL

    • Do not leave canisters open during storage

    • Do not reuse wipe

    • Dispose of used wipe in trash

    • Do not reuse or refill canister. Offer for recycling if available

    Made in Turkey

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    JANITEX ANTIBACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79519-021
    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)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    SODIUM LAURIMINODIPROPIONATE (UNII: 7G447D0DH9)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79519-021-01160 in 1 CANISTER09/18/2020
    13 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 finalpart333A09/18/2020
    Labeler - Pacific Health Systems Inc. (080638960)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!