Label: HAND SANITIZER SOLUTION 101- benzalkonium chloride liquid

  • NDC Code(s): 50241-224-01, 50241-224-02, 50241-224-08, 50241-224-09
  • Packager: Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 14, 2023

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

  • Active Ingredient

    Benzalkonium Chloride....0.13%

  • Purpose

    Antimicrobial

  • Warnings

    For external use only.
    Flammable keep away from fire or flame

  • When using this product

    Avoid contact with the eyes

    In case of eye contact, flush eyes with water.

  • Stop use and ask doctor if

    irritation or redness develops, if conditions persisit for more than 72 hours.

  • Keep out of reach of children

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

  • Uses

    For Hand Sanitizing to decrease bacteria on the skin.

  • Inactive Ingredients

    Water, Isopropyl Alcohol

  • Directions

    Wash hands with soap and water. Rinse with potable water. Wet entire surface of hands with product especially the cuticles and fingernails. Rub hands together until dry. Do not rinse hands. Re-apply as needed.

  • Hand Sanitizer Solution 101

    image description
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER SOLUTION 101 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50241-224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50241-224-024 in 1 BOX04/14/2018
    1NDC:50241-224-013.67 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:50241-224-08201.85 kg in 1 DRUM; Type 0: Not a Combination Product12/08/2021
    3NDC:50241-224-091009.25 kg in 1 CONTAINER; Type 0: Not a Combination Product12/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/14/2018
    Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
    Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.028311595manufacture(50241-224) , api manufacture(50241-224) , pack(50241-224)