Label: BORTONS MENTICOL - alcohol and menthol liquid 

  • Label RSS
  • NDC Code(s): 50790-200-16
  • Packager: J-Mark International Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/10

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

  • ACTIVE INGREDIENT

    Drug Facts/Medicamento

    Active Ingredients/Ingredients activo            Purpose/Proposito

    Ethyl Alcohol/Alcohol Etilico 69.5%             Antiseptic/Antiseptico

    Methol/Mentol 1%                                      Topical Anagesic/Anagesico topico


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  • PURPOSE

     USES/USO  

    First Aid to help reduce the risk of infection in minor cuts and scrapes/Primeros Auxillos para ayudar a reducir el riegsgo de infeccion en cortadas menores y raspones


    For temporary relief of itching associated with insect bites. Para ailvio temporal de: comezon asociado con picaduras de insecto

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  • WARNINGS

    Warnings/Advertencias

    For external use only. do not use in or near the eyes. In case of deep or puncture wounds consult your doctor/ Para uso externo solamente. No para uso serca de los ojos. En caso de erina profunda, consulte con un doctor



    Flammable, keep away from fire or flame. Flamable, mantenga alejado del fuego or flama



    Avoid contact with the eyes/Eveitar contacto con los oj



    If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor./Si la condicion empeora o si los sintomas persisten por mas de 7 dias o desaparecen u ocurren nuevamente en pocos dias, descontinue el uso de este producto y consulte a un doctor



    Keep out of reach of children/Mantengase alejado del alcance de los ninos



    If swallowed, get medical help or contact Poison Control Center right away. Si es ingerido, obtenga ayuda medica o contacte el centro de control de envenamientos de inmediato.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS/DIRECCIONES

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Adultos y ninos de 2 anos de edad en adelante: Aplica en el area afectada no mas de 3 a 4 veces diarias

    Apply to skin directly or with clean gauze, cotton, or swab./Aplicar directamente a la piel o con una gasa limpia, algodon, o isopo

    Children under 2 years of age: consult a doctor/Ninos menores de 2 anos de edad: consultar a un doctor.

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  • INACTIVE INGREDIENT

    FDandC Red/Rojo 40, water/ agua

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  • INFORMATION FOR PATIENTS

    For you protection, this bottle has an imprinted seal around the cap. Do not use if tamper evident seal is missing, tampered, broken or destroyed./Para su proteccion, esta botella tiene un sello impreso alrededor de la tapa. No use si el sello falta, ha sido alterado, roto o destruido

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  • SPL UNCLASSIFIED SECTION

    Distributed by/Distribuido por

    J-MARK International Inc.

    0819-03925

    Panama


    Made In/Hecho en Panama

    Expiration Date/Fecha de Expiracion 12/2015


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  • PRINCIPAL DISPLAY PANEL

    Borton's Menticol

    First Aid Antiseptic

    Pain Relieving Liniment

    Linimentoantiseptico para primeros

    auxilios y aliviar el dolor



    Net contents/Contenido Neto 16 fl oz (473 ml)

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  • INGREDIENTS AND APPEARANCE
    BORTONS MENTICOL 
    ethyl alcohol, menthol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50790-200
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 69.5 mL  in 100 mL
    MENTHOL (MENTHOL) MENTHOL 1 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50790-200-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333 05/06/2010
    Labeler - J-Mark International Inc (853770001)
    Registrant - J-Mark International Inc (853770001)
    Establishment
    Name Address ID/FEI Business Operations
    J-Mark International Inc 853770001 manufacture
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