Label: ANTIMICROBIAL FOAMING SANITIZER- benzethonium chloride liquid 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 November 6, 2018

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  • DRUG FACTS

    Foaming Antimicrobial Sanitizer

  • Active Ingredient

    Benzethonium Chloride 0.2%

  • PURPOSE

    Antimicrobial

  • Inactive Ingredients

    Water,Lauramidopropyl Betaine, Propylene Glycol, Diazolidinyl Urea, Methylparaben,Propylparaben.

  • Purpose

    First Aid Antimicrobial Sanitizer

  • Use

    Kleer-Plex is a unique, non-drying sanitizer. Designed for all skin types and pH balanced. Kills 99.9% of germs including Staph,

    Pseudomonas, and E. coli. Excellent for post-operative care. May be used as a First Aid Antimicrobial to help protect against

    skin infection.

  • Warnings

    External use only. Do not use in eyes. In case of deep wounds or puncture wounds, consult a physician. If irritation develops and persists for more than a few days, discontinue use and consult a physician. .

  • Keep Out Of Reach Of Children

  • Other Information

    Alcohol Free

    Moisturizes

    Made In USA

  • QUESTIONS

    Questions or Comments

    Bio-Medical & Pharm., Mfg. Corp.

    4311 South Dr., Houston, TX 77053

    Phone: 281.835.8051

    Internet: www.kleerplex.com

  • Directions

    Dispense foam into palms, then spread onto hands and other areas to be treated.

  • PRINCIPAL DISPLAY PANEL

    Antimicrobial Foaming SanitizerKleer-Plex

    ANTIMICROBIAL

    FOAMING

    SANITIZER

    7.0 fl oz | 207 ml

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL FOAMING SANITIZER 
    benzethonium chloride liquid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37945-718
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    2-HEXENAL PROPYLENE GLYCOL ACETAL, (1E)- (UNII: ZBS49DF5S4)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37945-718-14207 g in 1 BOTTLE; Type 0: Not a Combination Product10/09/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/09/2015
    Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-718)
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