Label: MERTODOL SOLUTION- benzalkonium chloride liquid

  • NDC Code(s): 65055-201-01, 65055-201-02
  • Packager: Laboratorios Jaloma, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • Active Ingridients

    Benzalkonium Chloride 0.13%

    Purpose

    Antiseptic

  • Uses

    First aid to help prevent infection in *minor cuts *scrapes *burns

  • Warnings

    -For external use only

    -Do not use in the eyes or apply over large areas of the body

    Consult a doctor in case of

    - deep or puncture wounds

    -animal bites

    -serious burns

    -Stop use and consult a doctor if the condition persist or gets worse

    -do not use longer than 1 week, unless directed by a doctor

  • Keep out of the reach of children.

       In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediatley.

  • Directions.

    -Clean the affected area

    -Apply a small amount of this product on the area 1 to 3 times daily

    - May be covered with a sterile bandage

  • Inactive Ingredients

    Acetone, Alcohol, d & c red No. 22, water.

  • Labels

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  • INGREDIENTS AND APPEARANCE
    MERTODOL SOLUTION 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65055-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65055-201-0240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/24/201609/24/2016
    2NDC:65055-201-0125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00308/24/2016
    Labeler - Laboratorios Jaloma, S.A. de C.V. (811122357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Jaloma, S.A. de C.V.811122357manufacture(65055-201)
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