Label: MEDI DEFENSE MPULSE HAND SANITIZER- benzalkonium chloride spray

  • NDC Code(s): 73795-001-01, 73795-001-02, 73795-001-03, 73795-001-04, view more
    73795-001-05, 73795-001-06, 73795-001-07
  • Packager: CLEARSTREAM TECHNOLOGIES, LLC
  • 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 May 23, 2023

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  • Active ingredient

    Benzalkonium Chloride  0.13%

    Purpose

    Antimicrobial

  • Uses

    Help reduce bacteria on the skin.

    Recommended for repeated use

  • Warnings

    For external use only.

    Avoid contact with eyes. In case of eye contact flush thoroughly with water.

    Keep out of reach of children.

  • Directions

    • Apply product to hands and rub until dry.
  • Storage

    Store in cool dry place between 35 0 and 103 0F

  • Inactive ingredients

    Deionized Water, Propylene glycol, Triethylene glycol, PEG-75 Lanolin complex, Organo Silane Quaternaries

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    MEDI DEFENSE MPULSE HAND SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73795-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73795-001-0159.14 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/21/2020
    2NDC:73795-001-02236.58 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/21/2020
    3NDC:73795-001-033785.41 mL in 1 DRUM; Type 0: Not a Combination Product03/21/2020
    4NDC:73795-001-0418927.1 mL in 1 DRUM; Type 0: Not a Combination Product03/21/2020
    5NDC:73795-001-05208198 mL in 1 DRUM; Type 0: Not a Combination Product03/21/2020
    6NDC:73795-001-061040987.75 mL in 1 JUG; Type 0: Not a Combination Product03/21/2020
    7NDC:73795-001-07500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/21/2020
    Labeler - CLEARSTREAM TECHNOLOGIES, LLC (116962029)
    Establishment
    NameAddressID/FEIBusiness Operations
    TOLL SOLUTIONS LLC004854914manufacture(73795-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    RWM Technologies LLC626626969manufacture(73795-001)
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