Label: GUNK GETTER SANITIZING- benzalkonium chloride spray

  • NDC Code(s): 83590-002-01, 83590-002-02, 83590-002-03, 83590-002-04, view more
    83590-002-05
  • Packager: PeerBasics 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 August 24, 2023

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

  • Active Ingredient

    Benzalkonium Chloride

    Lauramide Propyl Dimethyl Oxide Amine

  • Purpose

    Antimicrobial Agent

    Surfactant

    Antifugal

  • Use

    Use to decrase bacteria on the skin.

  • Warnings

    For external use only

    Do not use

    Do not use it you are allergic to any of the ingredients.

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin.
    • do not inhale or ingest.

    Stop use and ask a doctor if

    irritation or rash develops and continues for more than72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years and over:

    • apply to hands.
    • allow skin to dry without wiping.
    • children under 2 years: ask a doctor before use.
  • Other information

    • do not store above 105F(41C).
    • may discolor some fabrics.
    • harmful to wood finishes and plastics.
  • Inactive Ingredients

    Water

    Glycerol

    Fungicide

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    GUNK GETTER SANITIZING 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83590-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) (LAURAMIDOPROPYLAMINE OXIDE - UNII:I6KX160QTV) LAURAMIDOPROPYLAMINE OXIDE1.5 mg  in 100 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83590-002-0180 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/20/2023
    2NDC:83590-002-0298 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/20/2023
    3NDC:83590-002-03473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/20/2023
    4NDC:83590-002-04828 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/20/2023
    5NDC:83590-002-05946 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2023
    Labeler - PeerBasics LLC (087291627)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Huiji Biotechnology Co.,Ltd526893497manufacture(83590-002)