Label: MG FOAMSAN- benzalkonium chloride liquid

  • NDC Code(s): 50241-522-01, 50241-522-03
  • 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 13, 2023

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

  • ACTIVE INGREDIENT

    Benzalkonium Chloride ...........0.1%

  • Purpose

    Antimicrobial

  • Uses

    For hand sanitizing to decrease bacteria on the skin.

    recommended for repeated use.

  • Warnings

    For external use only.

  • When Using this Product

    - Avoid contact with eyes.

    - In case of eye contact, flush eyes with water.

  • Stop use and ask a doctor if

    -Irritation or redness develops, if condition persists for more than 72 hours. 

  • Keep out of reach of children.

    Keep out of reach of children. If swallowed, get medical help

    or contact a Poison Control Center immediately.

  • Directions

    -Pump a small amount of foam into palm of hand.  

    -Rub thoroughly over all surfaces of both hands.  

    -Rub hands together brisky until dry

  • Inactive Ingredients

    Water, Cocamidopropyl PG-dimonium Chloride Phosphate, Dihydroxyethyl cocamine oxide, acetamidoethoxyethanol, citric acid.

  • MG DermaFoam

    image description
  • INGREDIENTS AND APPEARANCE
    MG FOAMSAN 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50241-522
    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)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50241-522-013785 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    2NDC:50241-522-03208198 g in 1 DRUM; Type 0: Not a Combination Product05/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/26/2020
    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(50241-522) , api manufacture(50241-522) , pack(50241-522)